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Home
  • About
      1. Board of Directors
      2. Our Staff
      3. Annual Reports
      4. Policies
      5. Fellowship
      6. Careers
  • Projects
      1. Column 1
        1. Animal Health & Veterinary Medicine
          1. Antimicrobial Use in Food Animals
          2. Industry SWOT Analysis
        2. Expanded Access
          1. E-request App
          2. Navigator
          3. Resources for COVID-19
        3. FDA Patient Listening Sessions
        4. Food & Nutrition
          1. About
          2. Food Traceability
          3. Healthy Rule Roundtables
          4. Nutrition Facts Label
          5. Produce Safety Stakeholder Dialogue
          6. Retail Dietitian Toolkit
      2. Column 2
        1. Improving Access to FDA Information
          1. Understanding FDA & FDA-Regulated Products
          2. Improving Access to Publicly Available FDA Information
        2. Research
          1. About
          2. Cross-Sectoral Health Threats
          3. IMEDS
          4. Post Market Research
          5. RAISE
          6. Real World Data
          7. Regulatory Science Accelerator
        3. Substance Use Disorders
  • News and Events
      1. Innovations in Regulatory Science & Policy Awards
      2. 2024 Annual Public Meeting
      3. Events
      4. News
      5. Publications
  • Expanded Access eRequest

News and Events

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  • Tuesday, December 09, 2025
    Innovations in Regulatory Science & Policy Awards
    Nominations Open! Help Us Recognize Leaders, Innovators, & Advocates
    Read More
  • Thursday, May 22, 2025
    Primary Mitochondrial Diseases
    The Reagan-Udall Foundation for the FDA, in collaboration with the Food and Drug Administration (FDA), will host a virtual, public workshop to explore opportunities to optimize therapeutic development to address primary mitochondrial diseases.
    Read More
  • Thursday, May 08, 2025
    TIME 100 Health 2025: David Fajgenbaum
    Dr. David Fajgenbaum was a third-year medical student when he “got critically ill out of nowhere.
    Read More
  • Thursday, May 08, 2025
    TIME 100 Health 2025: Sumbul Desai
    Dr. Sumbul Desai’s job is to think creatively about the different ways that technology can improve health.
    Read More
  • Thursday, May 08, 2025
    Call for Nominations for the 2025 Innovations in Regulatory Science & Policy Awards
    The Reagan-Udall Foundation for the FDA (the Foundation) seeks nominations for its annual Innovations in Regulatory Science & Policy Awards.
    Read More
  • Monday, May 05, 2025
    Quality Assurance Magazine: Researchers Suggest User Fees Could Help FDA Ensure Food Safety
    The agency’s lack of resources was documented in the Reagan Udall Foundation’s 2022 operational evaluation of the FDA’s Human Foods Program, an assessment former FDA Commissioner Robert Califf requested to help the agency make changes to better carry out…
    Read More
  • Thursday, May 01, 2025
    Pride Publishing Group: Meharry Medical College Homecoming Reunion and Commencement
    Georges C. Benjamin, M.D., is a well – known health policy leader, practitioner and administrator. He currently serves as the executive director of the American Public Health Association, the nation’s oldest and largest organization of public health…
    Read More
  • Wednesday, April 30, 2025
    CSP Daily News: After Mass Layoffs at the FDA's Center for Tobacco Products, What Happens Next?
    Zeroing in on what is needed to improve operations, including the PMTA process, Booth said a review of the Reagan-Udall Foundation report is critical.
    Read More
  • Tuesday, April 29, 2025
    U.S. Right to Know: FDA layoffs will hamper efforts to cut antimicrobial overuse in farm animals
    In 2023, the Reagan-Udall Foundation published plans for a public private partnership with industry to voluntarily collect data on the use of antimicrobials in farm animals.
    Read More
  • Tuesday, April 29, 2025
    The ASCO Post: Richard Pazdur, MD, Honored With 2025 AACR Enduring Impact Award for Transformative Service to Cancer Science and Medicine
    In addition to the new AACR award, Dr. Pazdur has received numerous awards and honors throughout his career: the Regulatory Affairs Professionals Society Patient-Centered Health Award (2021), the University of Chicago Cancer Research Foundation Simon M.…
    Read More
  • Friday, April 18, 2025
    CDC Foundation: Reed V. Tuckson Receives 2025 Elizabeth Fries Health Education Award
    I am delighted to share that Reed V. Tuckson, MD, FACP, yesterday received the 2025 Elizabeth Fries Health Education Award at the annual meeting of the Society for Public Health Education (SOPHE).
    Read More
  • Wednesday, April 16, 2025
    Tax Foundation: Opportunities to Reform the Food and Drug Administration’s Center for Tobacco Products
    In 2022, the FDA requested the Reagan Udall Foundation conduct an independent investigation of the CTP. The resulting report highlighted several shortcomings, including a lack of a clear regulatory and product approval framework, an inefficient and slow…
    Read More
  • Tuesday, April 08, 2025
    National Security Commission on Emerging Biotechnology: Charting the Future of Biotechnology
    Regulatory agencies need access to external experts in order to improve regulatory processes, scan the horizon for emerging technologies, and engage with the public, among other activities. Government-affiliated foundations provide a flexible and…
    Read More
  • Friday, April 04, 2025
    Townhall: Dismantling the FDA’s Tobacco Office Marks a New Beginning
    The failures of the CTP are well-documented. In 2022, an independent review by the Reagan-Udall Foundation found that the agency was in disarray, manipulated by outside interests rather than driven by scientific evidence.
    Read More
  • Thursday, April 03, 2025
    Consumer Federation of America: Taking the Chainsaw to Food Safety
    The FDA’s recent reorganization illustrates the value of transparency—radical or otherwise—to industry and consumers alike. In the wake of an infant formula crisis that justifiably incensed the public and lawmakers, the agency relied on extensive…
    Read More
  • Tuesday, April 01, 2025
    Vaping 360: Brian King Out at FDA Tobacco Center
    A 2022 report by the Reagan-Udall Foundation concluded that the CTP had failed in its primary role as a product regulator.
    Read More
  • Wednesday, March 26, 2025
    Vaping 360: Will New FDA Commissioner Martin Makary Save Vaping?
    A December 2022 report by the Reagan-Udall Foundation found the CTP had failed in its primary mission to regulate.
    Read More
  • Thursday, March 20, 2025
    Biomedicines Journal: Scientific Advancements in Gene Therapies: Opportunities for Global Regulatory Convergence
    On 4 September 2024, the Reagan-Udall Foundation for the FDA (FDA Foundation) in collaboration with the Food and Drug Administration (FDA) and the Gates Foundation hosted a workshop titled “Scientific Advancements in Gene Therapies: Opportunities for…
    Read More
  • Friday, March 07, 2025
    Clinical Leader: Trends In FDA FY 2024 Inspection-Based Warning Letters
    Importantly, on October 1, 2024, the FDA implemented a long-planned reorganization of the Human Foods Program and the FDA field operations in response to the Reagan-Udall Foundation Evaluation published in 2022.
    Read More
  • Thursday, February 27, 2025
    BioCentury: The next rare disease roadblock: American innovation moving ex-U.S.
    Members of the consortium have had an ongoing dialogue with the hub, Critical Path Institute, the Reagan-Udall Foundation, and AMP ALS since mid-2024.
    Read More
  • Friday, February 21, 2025
    Bio.News: BIO celebrates release of FDA Rare Disease Innovation Hub 2025 strategic plan
    In anticipation of the 2025 Strategic Agenda, the Reagan-Udall Foundation and the FDA co-hosted a stakeholder meeting where the FDA received input on what the Hub should prioritize. Dr. Flores represented BIO in the October 2024 meeting.
    Read More
  • Thursday, January 23, 2025
    Institute of Food Technologists: Countdown to Compliance
    On the FDA’s behalf, the Reagan-Udall Foundation has held roundtables with industry members to share insights, identify and prioritize key issues, and explore implementation strategies.
    Read More
  • Tuesday, January 21, 2025
    Food Safety Magazine: Food Safety in Transition: Looking Toward FSMA 204 Compliance
    Additionally, the Reagan-Udall Foundation held a series of roundtables with industry members to share insights from those involved in implementation, identify and prioritize key issues, and explore implementation strategies.
    Read More
  • Friday, January 17, 2025
    Medscape: FDA Pushes for Buprenorphine Labeling Changes to Facilitate Higher Doses
    The FDA noted that a Reagan-Udall Foundation public meeting in the spring of 2023 — with FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) — and a December 2023 meeting with FDA, SAMHSA, and the National Institute on Drug…
    Read More
  • Thursday, January 16, 2025
    Food Navigator USA: Does FDA's proposed front-of-pack nutrition labeling miss the mark?
    Her sentiments echo concerns raised by the Rudd Center for Food Policy & Health at a public meeting hosted by The Reagan-Udall Foundation for FDA in November 2023.
    Read More
  • Monday, January 06, 2025
    Food Logistics: FSMA 204 Compliance to Fundamentally Change How the Cold Chain Works
    “Our team has had over 185 meetings across industry sectors and answered over 400 questions through our technical assistance network. We also worked with the Reagan-Udall Foundation to meet with industry through a series of roundtables and the public…
    Read More
  • Friday, December 27, 2024
    Federal Register: Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence
    In May 2023, the Reagan-Udall Foundation hosted a 2-day public meeting with FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA), entitled “Considerations for Buprenorphine Initiation and Maintenance Care.”
    Read More
  • Thursday, December 26, 2024
    EIN Presswire: FDA recommends changes to labeling for transmucosal buprenorphine products indicated to treat opioid use disorder
    We also received similar feedback through several meetings in which FDA participated, including a two-day public meeting with the Reagan-Udall Foundation for the FDA in May 2023 and two listening sessions led by the Substance Abuse and Mental Health…
    Read More
  • Thursday, December 19, 2024
    Ultragenyx: Ultragenyx Submits Biologics License Application to the U.S. FDA for UX111 AAV Gene Therapy for the Treatment of Sanfilippo Syndrome Type A (MPS IIIA)
    Earlier this year, Ultragenyx reached agreement with the Agency that CSF HS can be used as a surrogate endpoint for accelerated approval based on the body of data presented by the company, along with a consortium of academics and other industry sponsors…
    Read More
  • Thursday, December 12, 2024
    Providers, You Are the Missing Piece: Your Patients with OUD Need You
    Drs. Robert Califf and Marta Sokolowska underscore the distinctive advantages primary care providers can bring to positively impacting the lives of people with opioid use disorder, referencing the Foundation’s virtual public meeting exploring “…
    Read More
  • Tuesday, December 10, 2024
    2024 Innovations in Regulatory Science Awards
    Read More
  • Thursday, December 05, 2024
    R Street Institute: Vaping goes to the Supreme Court
    In the fall of 2022, the Reagan-Udall Foundation—an independent organization established by Congress to advance the mission of the FDA—evaluated the CTP and identified several key areas for improvement. Released in December 2022, the report outlined 15…
    Read More
  • Sunday, December 01, 2024
    Food Safety News: FDA’s sluggish process is failing to protect Celiacs
    Jax’s Citizen Petition represents a perfect opportunity for the FDA’s Human Foods Program under Deputy Commissioner Jones to lead by example and break away from the Reagan-Udall Foundation’s finding that the FDA’s “culture creates an environment where…
    Read More
  • Friday, November 22, 2024
    Real-World Evidence Webinar Series: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
    The Reagan-Udall Foundation for the FDA, in collaboration with the Food and Drug Administration (FDA), hosted a public webinar as part of a series of webinars for FDA-issued guidance related to real-world evidence (RWE).
    Read More
  • Thursday, November 21, 2024
    U.S. Food & Drug Administration: FDA Patient Engagement Partnerships
    Through this collaboration, the Public Engagement Staff and the Foundation are working together on FDA Patient Listening Sessions to enhance FDA’s clinical and regulatory understanding of diseases and conditions and provide a common understanding of the…
    Read More
  • Friday, November 08, 2024
    Michael Best: The FDA's new Human Foods Program is here. What changes can we expect?
    By December of 2023, a reorganization package based in part on the findings and recommendations of the Reagan-Udall Foundation's evaluation of the agency's infant formula response, and feedback from external and internal stakeholders, was completed.
    Read More
  • Friday, November 08, 2024
    Consumer Brands Association: What the FDA’s Unified Human Foods Program Means for Agency Modernization
    We want to see the FDA use this momentum to keep focus on its core mission of food safety, make the cultural changes called for in the Reagan Udall Foundation’s report, and send a distinct signal that a strong, federal agency is protecting the health and…
    Read More
  • Tuesday, November 05, 2024
    American Association of Swine Veterinarians: Survey: Addressing Unmet Need Within the Animal and Veterinary Industries
    The Reagan-Udall Foundation for the FDA is leading an initiative to identify holistic approaches to address opportunities and challenges in animal health and veterinary medicine.
    Read More
  • Friday, November 01, 2024
    Pharmaceutical Technology: FDA Rare Disease Innovation Moves Forward
    In establishing the Hub, FDA gathered feedback from stakeholders through a public meeting, held on Oct. 16, 2024 in collaboration with the Reagan-Udall Foundation.
    Read More
  • Friday, November 01, 2024
    U.S. Food & Drug Administration: FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub
    In collaboration with the Reagan-Udall Foundation for the FDA, we hosted a public meeting, Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub, on October 16, 2024.
    Read More
  • Thursday, October 31, 2024
    Benzinga: FDA Public Meeting Reveals Federal Support For Psychedelics In PTSD Care
    Federal agencies recently convened in a pivotal public meeting, hosted by the Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA), to discuss emerging treatments for post-traumatic stress disorder (PTSD), with a focus on the potential…
    Read More
  • Wednesday, October 30, 2024
    Introduction to Innovation in Medical Evidence and Development Surveillance (IMEDS): The Research Resource
    On October 30, 2024, we held a one-hour session on IMEDS, a flagship program of the Regan-Udall Foundation for the FDA.
    Read More
  • Wednesday, October 30, 2024
    Biosimilar Roundtables
    The Reagan-Udall Foundation for the FDA conducted a series of five closed-door virtual roundtable conversations with biosimilar developers to explore emerging areas of regulatory science and to create a space for active discussion and exploration between…
    Read More
  • Tuesday, October 29, 2024
    Food Safety News: Transforming FDA-regulated food products: A webinar with Jim Jones
    The reorganization had its origins in the Reagan-Udall Foundation report, which was released less than two years ago. The report focused on ways to clarify the mission of the human food program and achieve more urgency in preventing foodborne illnesses.
    Read More
  • Monday, October 28, 2024
    The Evidence Base: Advancing real-world data research through the Innovation in Medical Evidence and Development Surveillance (IMEDS) program: an interview with Carla Rodriguez-Watson, Reagan-Udall Foundation for the FDA
    Advancing real-world data research through the Innovation in Medical Evidence and Development Surveillance (IMEDS) program: an interview with Carla Rodriguez-Watson, Reagan-Udall Foundation for the FDA.
    Read More
  • Monday, October 28, 2024
    LDT Industry Education: Record Keeping and Adverse Event Reporting
    Record Keeping and Adverse Event Reporting: Medical Device Reporting, Corrections and Removals and Quality System Complaint Requirements LDT Industry Education
    Read More
  • Sunday, October 27, 2024
    Wiley Online Library: The Oncology QCARD Initiative: Fostering efficient evaluation of initial real-world data proposals
    The oncology quality, characterization, and assessment of real-world data (Oncology QCARD) Initiative was formed to develop a set of minimum study design and data elements needed to evaluate the fitness of the real-world data (RWD) source(s) proposed in…
    Read More
  • Friday, October 25, 2024
    BioCentury: Perspective: A path forward for rare disease policy
    The rare disease policy calendar in Washington has been packed. Highlights have included an advisory committee meeting for a Barth syndrome treatment from Stealth BioTherapeutics, a meeting about FDA’s Rare Disease Innovation Hub convened by the Reagan-…
    Read More
  • Tuesday, October 22, 2024
    Food Navigator: Food Traceability Rule compliance threatened by too much tech, over-eager realtors
    Food industry players across the value chain are frustrated by lingering questions about how to implement sweeping food safety changes that go into effect in little over a year, including fears of some stakeholders “going berserk” with new technology or…
    Read More
  • Monday, October 21, 2024
    Pharmacy Times: Review of 3 Alternative Pathways to Access Non–FDA-Approved Drugs
    Recently, the FDA has taken additional actions to clarify and streamline its policies regarding the EA process, including issuing guidance documents on EA, restructuring the FDA web page on EA, launching Project Facilitate (a call and information center…
    Read More
  • Monday, October 21, 2024
    Nutritional Outlook: Deputy Commissioner of Human Foods Program emphasizes efficiencies behind new agency reorganization
    Jones who was previously an official at the Environmental Protection Agency, was also on the Reagan-Udall Foundation panel that published an evaluation of FDA’s HFP which made recommendations for the reorganization of FDA’s HFP.
    Read More
  • Thursday, October 17, 2024
    STAT: The biggest challenge facing the FDA’s new Rare Disease Innovation Hub
    This came up early and often during the Reagan-Udall Foundation’s public meeting on Wednesday, “Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub,” that brought together rare disease patient advocates, academic researchers,…
    Read More
  • Thursday, October 17, 2024
    Medscape: MDMA Is Off the Table, So What’s Next for PTSD?
    So with MDMA-AT off the table, where does the field go next? A public meeting in September hosted by the Reagan-Udall Foundation for the FDA in sought to answer that question.
    Read More
  • Wednesday, October 16, 2024
    Western Growers: Reagan-Udall Foundation Seeks Input from Food Safety Leaders
    The industry, consumer and state regulatory members of the Fresh Produce Coalition (FPC) are pleased that the U.S. Food and Drug Administration is supporting the Reagan-Udall Foundation’s (RUF) facilitation of an inclusive stakeholder dialogue to explore…
    Read More
  • Wednesday, October 16, 2024
    Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub
    The Reagan-Udall Foundation for the FDA, in collaboration with FDA’s Rare Disease Innovation Hub, hosted a public meeting on October 16, 2024.
    Read More
  • Tuesday, October 15, 2024
    Food Safety Magazine: A Better Way to Clean Up the Food Mess: Creating a New "FAD"
    Complex and disparately funded regulatory oversight for food and beverage products, spread out among many federal agencies, has created a regulatory mess that demands a radical fix.
    Read More
  • Friday, October 11, 2024
    Steven A. Grossman, Jeff Shuren, and the Real-World Evidence Collaborative Recognized with Innovations in Regulatory Science Awards
    (October 11, 2024) Steven A. Grossman, JD; Jeff Shuren, MD, JD; and the Real-World Evidence Collaborative will receive the Reagan-Udall Foundation for the FDA’s 2024 Innovations in Regulatory Science Awards on December 10. The prestigious awards…
    Read More
  • Monday, October 07, 2024
    Virtual Public Meeting on FDA's Final Rule on Requirements for Additional Traceability Records for Certain Foods
    On October 7, we hosted a virtual public meeting to hear insights on the Final Rule on Requirements for Additional Traceability Records from both FDA leadership and other experts from across food industry sectors.
    Read More
  • Friday, October 04, 2024
    Keller & Heckman Law: A New Day Dawns at FDA with the Establishment of the Human Foods Program
    The report was prepared by an expert panel at the Reagan-Udall Foundation, convened at the request of Commissioner Califf, that was charged with assessing the processes and procedures, resourcing, and organizational structure for FDA’s Foods Program.
    Read More
  • Thursday, October 03, 2024
    Medidata: What’s Driving the Adoption of Clinical Trial to Real-world Data Linkage?
    In 2022, Medidata Link (Medidata’s linkage technology) won the Innovation Award from the Reagan Udall Foundation for the FDA, highlighting the excitement from the regulatory community towards linkage’s potential to reduce trial costs, timelines, and…
    Read More
  • Tuesday, October 01, 2024
    dvm360: FDA allocates funds for data collection and reporting on antimicrobial use in animals
    With antimicrobial resistance (AMR) continuing to grow as a global threat, the United States Food and Drug Administration (FDA) recently announced it is granting cooperative agreement funds for 3 projects focused on the collection, analysis, and data…
    Read More
  • Sunday, September 29, 2024
    Food & Wine: The FDA Is Launching New Traceability Rules for Added Food Safety — and Everyone Is Confused
    In September, the Reagan-Udall Foundation for the FDA released a report on three industry roundtables regarding the ruling. The participants in the invite-only roundtables called out three major areas of concern: awareness of the rules, labeling, and…
    Read More
  • Friday, September 27, 2024
    Magnetic: Food Traceability Rule to Hit January 2026
    The FDA’s Food Traceability Rule hits in January 2026. And a recent report from the Reagan-Udall Foundation found that retailers, suppliers, and distributors have no idea how it works.
    Read More
  • Thursday, September 26, 2024
    Main Line Times & Suburban: New approaches for a healthier Pennsylvania workforce [opinion]
    The FDA’s Center for Tobacco Products, or CTP, is responsible for reviewing these new products, but its process needs reform. According to a report from the Reagan-Udall Foundation, the CTP’s lack of transparency and communication has created significant…
    Read More
  • Wednesday, September 25, 2024
    Food Safety News: Three years in the making, FDA’s new Human Foods Program kicks off on Oct. 1
    Jones came to the FDA with intimate knowledge of the foods program, having served on the Reagan-Udall Foundation’s Independent Expert Panel, which evaluated it in 2022.
    Read More
  • Monday, September 23, 2024
    Produce Market Guide: FMI urges additional time and flexibility for traceability rule
    The Reagan-Udall Foundation also issued a report in September calling for staggered implementation of the traceability rule, starting with suppliers.
    Read More
  • Friday, September 20, 2024
    The Kitchn: The FDA May Add a Warning Label to Some of Your Favorite Foods — Here’s What This Means
    On November 16, 2023, the Reagan-Udall Foundation for the FDA hosted a virtual meeting to outline the proposed label changes. These new markings intend to help consumers quickly identify the details of food packaging; it should be especially helpful for…
    Read More
  • Friday, September 20, 2024
    FDA Roundup: September 20, 2024
    On Wednesday, the FDA’s Center for Veterinary Medicine announced that it is supporting a collaborative agreement to the Reagan-Udall Foundation for the FDA to conduct a strengths, weaknesses, opportunities, and threats (SWOT) analysis.
    Read More
  • Thursday, September 19, 2024
    JD Supra: Wrap-Up of Federal and State Chemical Regulatory Developments, September 2024
    To help support implementation, FDA worked with the Reagan-Udall Foundation to host three roundtable discussions on the Food Traceability Rule.
    Read More
  • Thursday, September 19, 2024
    American Association of Swine Veterinarians: Reagan-Udall Foundation to Research Challenges in Animal and Veterinary Industries
    As the U.S. Food and Drug Administration’s Center for Veterinary Medicine continues to progress in implementation of its Animal and Veterinary Innovation Agenda, the center is supporting a collaborative agreement to the Reagan-Udall Foundation for the…
    Read More
  • Wednesday, September 18, 2024
    dvm360: FDA shows commitment to animal and veterinary innovation
    In a continuation of progress towards the implementation of the AVIA, the FDA announced support for a collaboration agreement to the Reagan-Udall Foundation for the FDA.
    Read More
  • Tuesday, September 17, 2024
    Psychedelic Newswire: Federal Officials Admit Psychedelic Therapy Could Treat PTSD, Call for Additional Research
    The event was hosted by the Reagan-Udall Foundation for the FDA. While it didn’t center on psychedelic-assisted treatments only, many exchanged views on the topic. Read more
    Read More
  • Monday, September 16, 2024
    Tech UK: A simulation-first approach: In Silico Technologies for Medical Innovation in the Digital Era
    In Silico Methods drive scientific innovation by leveraging computer simulation instead of biological testing. Read more
    Read More
  • Friday, September 13, 2024
    The Microdose: Psychedelics and the social cure; Industry shake-ups; Tracking adverse events
    Last Friday, the Reagan-Udall Foundation held a public meeting to discuss the advancement of treatments for PTSD, which includes psychedelics.
    Read More
  • Friday, September 13, 2024
    Grocery Dive: Confusion persists with food traceability rule as compliance date nears
    A new report from the Reagan-Udall Foundation for the FDA explores which parts of the rule are confusing to executives that are working to bring their companies into alignment with the rule.
    Read More
  • Friday, September 13, 2024
    Philly Voice: The FDA wants to put nutrition warnings on the fronts of food packages to reduce obesity, other health conditions
    New labels would inform consumer whether the products are high in added sugars, sodium or saturated fats.
    Read More
  • Wednesday, September 11, 2024
    Benzinga: Multidisciplinary Association For Psychedelic Studies Eyes State-Level Legalization After FDA Denial Of MDMA Therapy
    The press conference followed the FDA and Reagan-Udall Foundation's public meeting on PTSD, which included discussions on psychedelic therapy. Read more
    Read More
  • Wednesday, September 11, 2024
    Green Market Report: FDA sidesteps MDMA controversy at PTSD meeting, but public pushes back
    The Sept. 6 hybrid public meeting, hosted by the Reagan-Udall Foundation for the FDA, drew experts, advocates and critics to discuss how to move forward advancing PTSD treatment. While the official agenda skirted the recent MDMA decision, public comments…
    Read More
  • Wednesday, September 11, 2024
    Agri-Pulse: Food system stakeholders push FDA for delayed, staggered traceability timeline
    In the spring, the Reagan-Udall Foundation for the FDA held a series of roundtable discussions with invited stakeholders. These conversations focused on the Food Safety Modernization Act’s Requirements for Additional Traceability Records for Certain…
    Read More
  • Wednesday, September 11, 2024
    Century of Lies Podcast: Psychedelics and PTSD Treatment
    The Reagan-Udall Foundation for the Food and Drug Administration is a nonprofit organization that was created by Congress to advance the mission of the FDA. The Foundation held a meeting recently entitled “Advancing Treatments for Post-Traumatic Stress…
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  • Tuesday, September 10, 2024
    Politico's Prescription Pulse: Accelerating PTSD Treatments
    Officials said Friday during a panel discussion — hosted by the FDA and the independent nonprofit Reagan-Udall Foundation for the FDA — that, while new treatments and drug approvals are needed, existing treatments aren’t being used to their full capacity.
    Read More
  • Tuesday, September 10, 2024
    Marijuana Moment: Federal Officials Say Psychedelic-Assisted Therapy Shows Promise For PTSD, But More Research Is Needed
    The discussion, hosted by the Reagan-Udall Foundation for the Food and Drug Administration, a nonprofit formed by Congress to support FDA, didn’t focus specifically on psychedelic-assisted therapies, but the topic nevertheless featured prominently—…
    Read More
  • Monday, September 09, 2024
    Filter Magazine: Psychedelic Advocates Air FDA Frustrations at Reagan-Udall Meeting
    On September 6, the Reagan-Udall Foundation for the Food and Drug Administration, an independent nonprofit created by Congress in 2007 to support the FDA’s mission, hosted a public meeting in Washington, DC, to discuss the latest advancements in post-…
    Read More
  • Friday, September 06, 2024
    HCP Live: Reagan Udall Foundation for FDA Facilitates Discussion on Urgent Needs in PTSD Therapy
    Reagan Udall Foundation for the US Food and Drug Administration (FDA), a non-profit organization created by Congress, hosted the hybrid public meeting “Advancing Treatments for Post-Traumatic Stress Disorder” on September 6, 2024.
    Read More
  • Friday, September 06, 2024
    FDA Roundup: September 6, 2024
    On Wednesday, the FDA issued a Constituent Update detailing efforts to enhance food traceability. Deputy Commissioner Jim Jones highlighted the FDA’s online resources regarding the Food Traceability Rule, as well as roundtables with the Reagan-Udall…
    Read More
  • Friday, September 06, 2024
    Advancing Treatments for Post-Traumatic Stress Disorder
    The Reagan-Udall Foundation for the FDA, in support of FDA’s ongoing focus on PTSD, convened “Advancing Treatments for Post-Traumatic Stress Disorder,” a public meeting with stakeholder comment.
    Read More
  • Thursday, September 05, 2024
    Food Safety Magazine: Report Highlights Industry Concerns With FSMA 204 Compliance, Barriers to Implementation
    Industry concerns about compliance with the U.S. Food and Drug Administration’s (FDA’s) impending Food Traceability Final Rule, which fulfills Section 204(d) of the Food Safety Modernization Act (FSMA), have been brought to light in a recently released…
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  • Thursday, September 05, 2024
    Progressive Grocer: FMI Urges More Time, Flexibility to Comply With Food Traceability Rule
    FMI – The Food Industry Association has expressed its support for the process set forth by the U.S. Food and Drug Administration (FDA) and the nonprofit Reagan-Udall Foundation to solicit feedback from stakeholders about the challenges involved in…
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  • Wednesday, September 04, 2024
    Scientific Advancements in Gene Therapies: Opportunities for Global Regulatory Convergence
    The Reagan-Udall Foundation for the FDA, in collaboration with the Bill & Melinda Gates Foundation, will host a hybrid public workshop on "Scientific Advancements in Gene Therapies: Opportunities for Global Regulatory Convergence."
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  • Wednesday, August 28, 2024
    AgriPulse: Opinion: Fresh produce industry has a traceability solution waiting for FDA's OK
    Subsequently, the Reagan-Udall Foundation was contracted by the FDA to conduct a series of three invitation-only industry stakeholder meetings focused on FSMA 204 implementation challenges. IFPA attended all of these.
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  • Friday, August 23, 2024
    The Washington Post: Matthew Perry started taking ketamine legally. That's never been easier.
    “This is like the weight-loss clinic,” Jenni Wai, Ohio’s chief pharmacist, said of ketamine providers at a June workshop held by the Reagan-Udall Foundation, a congressionally created nonprofit that advises the FDA. “This is like the med spas and the…
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  • Monday, August 19, 2024
    Vapor Voice: Principled Response
    “The Supreme Court’s decision elevates the importance of the Reagan-Udall Foundation’s findings after being convened at the request of the FDA commissioner, which specifically and clearly criticized the FDA’s Center for Tobacco Products for failing to…
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  • Friday, August 16, 2024
    Medtech Insight: News We're Watching: Globus Warning Letter, FDA Clears Traumagel, Reimbursement For Symplicity Spyral
    The meeting, which will be facilitated by the Reagan-Udall Foundation, will provide those in the rare disease community the opportunity to provide input on the priorities of the hub. The FDA plans for the hub to work across rare diseases but especially…
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  • Monday, August 12, 2024
    FDA Roundup: August 13, 2024
    On Monday, the FDA announced that it will hold a public meeting on October 16, 2024, titled, “Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub.” Read more
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  • Wednesday, August 07, 2024
    Government Executive: How the FDA could shape the future of psychedelics research
    FDA draft guidance posted in June 2023 provides a potential framework on how to overcome expectancy bias and the nocebo effect by employing an active placebo which could be a substance that also has mind-altering effects but no expected therapeutic…
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  • Tuesday, August 06, 2024
    Vapor Voice: FDA Posts 2 Regulatory Science Memos for Vapes
    In April, FDA resumed the posting of regulatory science policy memos, with a subsequent release in May. The release of these latest memos reflects the CTP’s ongoing commitment to enhance transparency consistent with the December 2022 evaluation of the…
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  • Tuesday, August 06, 2024
    Food Safety News: FDA's new Human Foods Program is recruiting its start-up talent to help Jim Jones
    In January 2023, the FDA announced it would develop a reorganization proposal to create a unified Human Foods Program and restructure its field operations (Office of Regulatory Affairs) after carefully reviewing the findings and recommendations of an…
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  • Thursday, August 01, 2024
    Produce Grower: FDA's new food boss
    Jones spent 30 years working at the U.S. Environmental Protection Agency, primarily as a pesticide regulator, and served on the Reagan-Udall Foundation’s Independent Expert Panel for Foods, which submitted a report on the operational evaluation of the…
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  • Wednesday, July 31, 2024
    Exponent: Accelerating Breakthroughs for FDA-Regulated Products
    The paper, titled "In Silico Technologies: A Strategic Imperative for Accelerating Breakthroughs and Market Leadership for FDA-Regulated Products," has been published online by Regulatory Science Accelerator (RSA), a platform developed by the Reagan-…
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  • Friday, July 26, 2024
    Reagan-Udall Foundation for the FDA Publishes RAISE Action Framework to Improve Race and Ethnicity Data Collection in Health Care
    (WASHINGTON, July 26, 2024) – The Reagan-Udall Foundation for the FDA (the Foundation) launched a new tool for leaders in health care delivery—the RAISE Action Framework.
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  • Thursday, July 25, 2024
    Food Safety Magazine: Another Evaluation of Infant Formula Crisis Concludes FDA Needs More Authorities to Prevent Shortages
    Among other recommendations, the NSAEM report reiterates other sentiments expressed by FDA and the Reagan-Udall Foundation, as well as consumer advocacy groups; specifically, that FDA’s authority to oversee manufacturing significantly hindered the agency…
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  • Thursday, July 25, 2024 - Friday, July 26, 2024
    Online Controlled Substances Summit
    The Food and Drug Administration (FDA) and the Reagan-Udall Foundation for the FDA convened the fifth Online Controlled Substances Summit.
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  • Tuesday, July 16, 2024
    Implementing the RAISE Action Framework
    Implementing the RAISE Action Framework Webinar July 16, 2024 | 2-3pm (eastern)  
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  • Wednesday, July 03, 2024
    FDA: Actions to Address Recommendations from the Reagan-Udall Evaluation of CTP
    In September 2022, per the request of the FDA Commissioner, Dr. Robert Califf, an independent expert panel facilitated by the Reagan-Udall Foundation began an operational evaluation of the agency’s Center for Tobacco Products (CTP). Read more
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  • Thursday, June 27, 2024
    The Potential of Ketamine: Public Workshop and New Research Explores Uses
    In collaboration with the US Food and Drug Administration (FDA), the Reagan-Udall Foundation for the FDA, is today hosting a hybrid public workshop on "Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest." Read more
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  • Thursday, June 27, 2024
    FDA: Medical Countermeasures Initiative (MCMi) Program Update
    This annual report provides an update on FDA's work to support medical countermeasure-related public health preparedness and response efforts. Read more
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  • Thursday, June 27, 2024
    Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest
    The Reagan-Udall Foundation for the FDA, in collaboration with the FDA, hosted a hybrid public workshop on "Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest."
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  • Tuesday, June 18, 2024
    Bio.News: BIO 2024: Can data improve clinical trial diversity?
    “One of the things that we’ve noticed, not just in the pandemic, is this problem of missing race and ethnicity information,” explained Carla Rodriguez-Watson, Ph.D., MPH, Director of Research at the Reagan-Udall Foundation for the FDA. “If you do not…
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  • Thursday, June 13, 2024
    Fierce Biotech: Ultragenyx wins surrogate endpoint debate, securing green light to seek FDA approval of gene therapy
    Ultragenyx Pharmaceutical's work to get the FDA to recognize a biomarker as a surrogate endpoint looks to have paid off. With the agency agreeing the biomarker is a reasonable surrogate endpoint, Ultragenyx is preparing to file for approval of its…
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  • Tuesday, June 11, 2024
    Boston Herald: New Research from Partnership for Advancing Clinical Trials (PACT) Reveals Decentralized Clinical Trials (DCTs) Beat Timeline Expectations
    Medable Inc., the leading technology provider for modern clinical trials, today announced that the Partnership for Advancing Clinical Trials (PACT) consortium in conjunction with the Tufts Center for the Study of Drug Development (CSDD) has produced…
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  • Monday, June 10, 2024
    ABC: Why the FDA might require nutrition labels on the front of food packages
    Soon there could be nutrition labels on the front of food packages at the grocery store — not just on the back or side. The Food and Drug Administration said the goal of potentially implementing this new label on prepackaged goods is to “help ensure that…
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  • Saturday, June 08, 2024
    NBC News: Could mandating nutrition labels on the front of food packages lower obesity rates?
    The Food and Drug Administration is expected to propose a change to prepackaged food sold in America: a requirement that the front of the packages display key nutrient information in addition to the nutrition label that’s already on the back. Read more
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  • Thursday, May 30, 2024
    Real-World Evidence Webinar Series: Considerations Regarding Non-Interventional Studies for Drug and Biological Products
    The Reagan-Udall Foundation for the FDA, in collaboration with the Food and Drug Administration (FDA), hosted a public webinar as part of a series of webinars for FDA-issued guidance related to real-world evidence (RWE).
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  • Tuesday, May 28, 2024
    Food Safety Matters Episode 170: Food Safety Magazine
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  • Tuesday, May 14, 2024
    Advocates: Engagement With Patients Key To Long-Term Registry Participation - Inside Health Policy
    Regular engagement with patients participating in registries is key to ensuring they continue to participate in long-term follow-up about a disease’s progression or the effectiveness of a treatment, leaders of patient advocate groups who have created…
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  • Monday, May 13, 2024
    Natural History Studies and Registries in the Development of Rare Disease Treatments
    The Reagan-Udall Foundation for the FDA, in collaboration with FDA’s Rare Diseases Team within the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine; Office of New Drugs; Center for Drug Evaluation and Research and the National…
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  • Tuesday, May 07, 2024
    2024 Annual Public Meeting
    Each year, the Reagan-Udall Foundation for the FDA conducts an annual public meeting to discuss its activities in support of the U.S. Food and Drug Administration.
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  • Wednesday, May 01, 2024
    Nominations Now Open for the 2024 Innovations in Regulatory Science Awards
    Nominations are now being accepted for the 2024 Innovations in Regulatory Science Awards. These awards will be presented at the Innovations in Regulatory Science Awards Gala on December 10, 2024 at the Willard InterContinental Hotel in Washington,…
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  • Monday, April 22, 2024
    FDA requests $7.2bn for FY2025 to unify Human Foods Program, strengthen data infrastructure
    FDA’s total request of $7.2bn for FY 2025, an increase of $341m from the FY 2024 numbers, “will allow the agency to continue to leverage new and emerging technologies,” and unite the Human Foods Program under “a single line of authority,” FDA…
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  • Wednesday, April 17, 2024
    A New Consortium on Sickle Cell - FDA Today
    This news that Reagan-Udall Foundation for the FDA and the ASH Research Collaborative have established a new Real-World-Evidence Consortium for Sickle Cell Disease which aims to "develop consensus recommendations on clinical outcomes important to…
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  • Wednesday, April 17, 2024
    ASH Research Collaborative and Reagan-Udall Foundation for the FDA Launch Sickle Cell Disease Real-World Data Project
    (WASHINGTON, April 17, 2024) –The ASH Research Collaborative (ASH RC) and the Reagan-Udall Foundation for the Food and Drug Administration (FDA Foundation) are launching the Real-World Evidence Consortium for Sickle Cell Disease (SCD) to develop…
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  • Friday, April 12, 2024
    Comer: The FDA Has Failed to Prioritize Safety and Incentivize Innovation
    WASHINGTON—House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) today opened a hearing titled “Oversight of the U.S. Food and Drug Administration” to bring transparency to a pattern of issues within the U.S. Food and…
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  • Thursday, April 11, 2024
    CVM director outlines long-term priorities - Agri-Pulse
    FDA’s Center for Veterinary Medicine is looking to modernize its legal authority and spur innovation over the next several years, according to CVM Director Tracey Forfa. Read more
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  • Monday, April 08, 2024
    Oversight Committee to Question FDA Commissioner - Tobacco Reporter Online
    The U.S. House Oversight and Accountability Committee will question U.S. Food and Drug Administration Commissioner Robert Califf as part of an investigation into the agency’s handling of tobacco and nicotine products regulation, among other issues,…
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  • Wednesday, April 03, 2024
    CTP Releases New 5-year Strategic Plan - LexBlog
    On December 18, 2023, Dr. Brian King, the Director of FDA’s Center for Tobacco Products announced the Center’s new five-year strategic plan which outlines the Center’s programmatic and workforce initiatives and includes five goals,…
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  • Friday, March 29, 2024
    FDA Roundup - Associated Press
    Today, the FDA is releasing several scientific review policy memoranda that provide a snapshot of the FDA's internal thinking on certain topics within the premarket tobacco review process.
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  • Wednesday, March 27, 2024
    Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER - Pink Sheet Citeline
    US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting…
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  • Thursday, March 21, 2024
    Amidst spreading infectious diseases and climate change, US FDA should renew its focus on neglected tropical diseases - PLoS One
    In 2015, the United States Food and Drug Administration (US FDA) and other Department of Health and Human Services agencies helped respond to a public health emergency concerning Zika Virus during which 5,600 cases of the virus were reported in the…
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  • Wednesday, March 20, 2024
    Jim Jones Looks Toward FDA's Future - Quality Assurance Magazine
    Every organization goes through ups and downs. And the Food and Drug Administration is no different. But the stakes are higher when you’re tasked with protecting public health. So, it’s understandable when “Put the F Back in FDA” started trending online…
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  • Thursday, March 07, 2024
    Lifesaving Narcan tough to find in Texas pharmacies - Texas Tribune
    When the U.S. Food and Drug Administration made the opioid overdose reversal drug naloxone an over-the-counter medication last summer, health care advocates praised the removal of the prescription barrier as an effective tool to prevent fentanyl deaths…
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  • Wednesday, March 06, 2024
    Reagan-Udall Foundation for the FDA Announces New Board Leaders, Members
    (March 6, 2024) The Reagan-Udall Foundation for the FDA has announced new officers and two new members of its Board of Directors.  Adrian F. Hernandez, MD, MHS, a Board member since 2019, has been elected to serve as the Board’s Vice Chair. Debra L…
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  • Wednesday, February 28, 2024
    Ultrarare inflection point: stakeholders argue for biomarker-based approvals - BioCentury
    A meeting convened by the Reagan-Udall Foundation for the FDA on qualifying rare disease biomarkers for accelerated approvals could be an inflection point for patients with ultrarare diseases, their families, biotech companies, and FDA. Read…
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  • Tuesday, February 27, 2024
    Accelerated approval will be 'the norm' for gene therapies, FDA's Peter Marks says - Endpoints
    The FDA will increasingly use accelerated approval for gene therapies aimed at rare conditions, according to Peter Marks, the FDA’s top official overseeing cell and gene therapies, the clearest signal yet of how widely the agency will deploy its…
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  • Monday, February 26, 2024
    Accelerating a Path to New Treatments for Rare Neuronopathic MPS Diseases - BioSpace
    At Denali Therapeutics, where I serve as chief medical officer and head of development, we are eager to develop new treatments for progressive and debilitating neuronopathic mucopolysaccharidoses diseases with our novel technology. We are not alone—…
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  • Wednesday, February 21, 2024
    For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards - Pink Sheet Citeline
    Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation…
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  • Wednesday, February 21, 2024
    Qualifying Biomarkers to Support Rare Disease Regulatory Pathways
    Qualifying Biomarkers to Support Rare Disease Regulatory Pathways Case example: Heparan sulfate in neuronopathic lysosomal storage diseases Public Workshop: In-Person and Virtual February 21, 2024 | 10am-4pm (eastern)
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  • Monday, February 19, 2024
    FDA tackles safety challenges related to ‘misinformation’ about CBD, food additives and how it makes science-based decisions - Nutra Ingredients
    Even as FDA stands by its decision that CBD is not safe for use in foods, beverages and dietary supplements, the agency is considering how best to ensure it is clearly labeled, safely manufactured and consumers understand what it is, according to a…
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  • Saturday, February 17, 2024
    FDA Officials Join Experts To Discuss Psychedelics Research Challenges And Promises - Marijuana Moment
    Officials with the Food and Drug Administration (FDA) recently joined scientists at a public meeting on next steps for conducting research to develop psychedelic medicines. Read more
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  • Friday, February 16, 2024
    It's past time to put an end to youth vaping. FDA needs to step up - Cincinnati Enquirer
    We, as a society, are past the point of vaping being a new trend. It is now an epidemic for our young people with unfortunately no end in sight if we don’t take action now. Read more
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  • Friday, February 02, 2024
    A cornucopia of new bills; Canadians support end-of-life psilocybin therapy; and tempering the hype - The Microdose
    The Reagan-Udall Foundation, a non-profit created to advance the work of the U.S. Food and Drug Administration, held a two-day conference this week on current psychedelic research and clinical study design.  Read more
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  • Wednesday, January 31, 2024 - Thursday, February 01, 2024
    Advancing Psychedelic Clinical Study Design
    Advancing Psychedelic Clinical Study Design Virtual Public Meeting Day 1: January 31, 2024 | 10am-2pm (eastern)
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  • Thursday, January 25, 2024
    FDA To Launch Largest Reorganization In History This Year - World Pharma Today
    It is well to be noted that a proposed FDA reorganization might as well have food safety first and foremost; however, stakeholders throughout industries will go on to feel the effects of what Michael Rogers, associate commissioner for regulatory affairs…
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  • Monday, January 22, 2024
    FDA reorganization is out for review, but impact later in 2024 could be huge - LexBlog
    The FDA’s largest reorganization in history, involving about 8,000 employees, is far more than just “moving some boxes around.”  The proposed changes and updates to an FDA-wide reorganization plan have been out for external reviews and clearances…
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  • Sunday, January 21, 2024
    VTA: CTP Continues ‘De-Facto’ Flavor Ban With MDOs - Vapor Voice
    When the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) issued marketing denial orders (MDOs) for Suorin and Blu PLUS+ e-cigarette products, Tony Abboud, executive director of the Vapor Technology Association (VTA), said the…
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  • Wednesday, January 17, 2024
    Major FDA reorganization will heavily impact human foods program - LexBlog
    What started as a crisis over the safety and supply of infant formula became a wide-ranging review of FDA’s food programs by the Reagan-Udall Foundation. Read more
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  • Monday, January 15, 2024
    FDA’s Center for Tobacco Products Publishes Strategic Plan - JD Supra
    The Food and Drug Administration’s Center for Tobacco Products (“CTP”) has released a strategic plan intended to guide the Center’s activity for the next five years.
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  • Sunday, January 14, 2024
    Reagan-Udall Foundation for the FDA Announces Hybrid Public Meeting on Qualifying Biomarkers to Support Rare Disease Regulatory Pathways
    What: The Reagan-Udall Foundation for the FDA will host a public workshop to explore primary disease activity biomarkers in rare genetic diseases.  Attendees will hear perspectives from patient advocates, researchers, regulators, and representatives…
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  • Friday, January 05, 2024
    FDA Roundup: January 5, 2024 - Associated Press
    On January 31 and February 1, the Reagan-Udall Foundation for the FDA, will hold a virtual public workshop, “Advancing Psychedelic Clinical Study DesignExternal Link Disclaimer.” This meeting will bring together researchers, regulated industry, and other…
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  • Sunday, December 31, 2023
    An Optimistic Look Back - Vapor Voice
    In February of this year, Vapor Voice published my reflections on my past 11 years affiliated with the vapor industry. And while many would say that the vapor industry has been a roller coaster, I remain firm in my belief that a place for vapor…
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  • Sunday, December 31, 2023
    Looking Back at the Vaping Industry in 2023 - Tobacco Reporter Online
    It remains a frustrating business environment. The vaping segment has survived despite setbacks in 2023 and continues growing as a global market. However, divergent regulatory perspectives on vaping’s harm reduction potential continue to hinder its…
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  • Friday, December 15, 2023
    FDA flubs guidance to restaurant industry on disclosing calories for menus on delivery platforms - The Center for Science in the Public Interest
    Americans deserve to know how many calories we’re ordering when we order restaurant meals. FDA regulations are clear: chain restaurants with 20 or more locations across the U.S. are required to post calories on their menus, including “menus on the…
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  • Thursday, December 14, 2023
    Senators Ask Califf to Explain FDA's PMTA Review Process - Vaping360
    A bipartisan trio of U.S. senators has sent a letter to FDA Commissioner Robert Califf, urging him to reform the agency’s tobacco product application process, and asking him to explain and clarify the FDA’s approach to nicotine product regulation. Read…
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  • Thursday, December 14, 2023
    Review after review must still be completed before changes can occur at the FDA - LexBlog
    It’s been 18 months since the FDA began studying problems in its Human Foods Program and an update from the agency says it will take more time to implement changes. The head of the Food and Drug Administration said on Dec. 13 that he is “hopeful” that…
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  • Wednesday, December 06, 2023
    NMPF Promotes Farm Program Efforts to Track Antibiotic Use in Livestock
    NMPF extolled the FARM antibiotic stewardship program in comments filed with the FDA on Oct.
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  • Wednesday, December 06, 2023
    Dr. Francis Collins, FDA’s GenomeTrakr, and Representative Diana DeGette and former Representative Fred Upton Recognized with Innovations in Regulatory Science Awards
    (December 4, 2023) The Reagan-Udall Foundation for the FDA will present Innovations in Regulatory Science Awards to Francis Collins, MD, GenomeTrakr, and jointly to Representative Diana DeGette (D-CO) and former Representative Fred Upton (R-MI) on…
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  • Tuesday, December 05, 2023
    FDA Principal Deputy Commissioner Woodcock’s successor Bumpus will help reorganize Human Foods Program - Food Navigator
    Just over a year after joining FDA as the agency’s top scientist, Namandjé Bumpus will rise to second in command as principal deputy commissioner early next year – replacing Janet Woodcock who, after nearly 40 years as a leader within the agency,…
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  • Tuesday, December 05, 2023
    2023 Innovations in Regulatory Science Awards
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  • Monday, December 04, 2023
    FDA Gets Earful on Front-of-Package Labeling - Thompson FDA
      The FDA heard recommendations from industry, academia and consumer groups on Front-of-Package Labeling (FOPL) at a recent public meeting hosted by the Reagan-Udall Foundation. Read more
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  • Monday, December 04, 2023
    State of the Industry Part 3: Communication, Education, and Trust - Nutraceuticals World Online
    Public health agencies like FDA are struggling with credibility issues and are focused on combating “misinformation.” Meanwhile, nutrition science is constantly evolving, and interpretation of new studies often leads to confusion.  Read more
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  • Monday, November 27, 2023
    Limiting front-of-pack nutrition labeling to added sugar, saturated fat & sodium could skew potential health impact, stakeholders tell FDA - FoodNavigator USA
    Front of package nutrition labeling intended to help consumers select healthier foods and beverages by potentially calling out the amount of added sugar and other nutrients of interest could unintentionally expose children to higher levels of non-…
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  • Monday, November 20, 2023
    FDA Announces Updates to Dietary Supplement Program - National Law Review
    On Aug. 14, 2023, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Robert Califf provided an update on changes to the Agency’s dietary supplement program, under the proposed human foods program redesign.  Read more
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  • Friday, November 17, 2023
    FDA Roundup - FDA Morning News Service
    Today, to mark the 15th anniversary of the FDA foreign offices, the FDA published an interview with Susan Winckler, who was FDA chief of staff when the first office was opened in Beijing on November 19, 2008.  Read more
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  • Friday, November 17, 2023
    New NIH Director To Focus On Strategies To Increase Clinical Trial Enrollment - Inside Health Policy
    A key focus for new National Institutes of Health (NIH) Director Monica Bertagnolli is spearheading innovative way to get more patients into in clinical trials to improve evidence generation, she said in recent remarks, including by getting providers…
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  • Thursday, November 16, 2023
    Front-of-Package Nutrition Labeling
    Front-of-Package Nutrition Labeling Virtual Public Meeting November 16, 2023 | 2:30-5pm (Eastern) On November 16 we convened a Front-of-Package Nutrition Labeling virtual public meeting that included opportunity for stakeholder comment.
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  • Wednesday, November 15, 2023
    Reagan-Udall Foundation Calls for Overhaul of Post-Market Evidence Generation System, Suggests FDA-Led Approach - Health Economics
    The Reagan-Udall Foundation asserts in a new report that the current post-market evidence generation system is expensive and time-consuming, with an urgent need for substantial changes. Read more
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  • Wednesday, November 15, 2023
    Can post-market evidence generation be streamlined? FDA-commissioned report proposes solutions - Endpoints
    As the FDA seeks to bring a greater focus to improving post-market evidence generation, a new report from the Reagan-Udall Foundation offers some potential solutions to the system it says is too costly and complicated. Read more
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  • Wednesday, November 15, 2023
    Report calls on FDA to lead task force on post-approval trials - POLITICO Pro
    The nonprofit Reagan-Udall Foundation that advises the FDA is recommending the agency lead an inter-agency and industry task force to streamline and strengthen post-approval studies of drugs and devices. Read more
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  • Tuesday, November 14, 2023
    Deputy commissioner discusses new FDA plans - Produce Blue Book
    The notorious contamination of infant formula over the winter of 2021-22 was a scandal not only for Abbot Nutrition, the product’s manufacturer, but for the federal Food and Drug Administration (FDA), which dawdled for five months before taking action.…
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  • Tuesday, November 14, 2023
    Integrating Clinical Studies Into Health Care Delivery: Post-Market Evidence Generation for Medical Products
    Integrating Clinical Studies Into Health Care Delivery: Post-Market Evidence Generation for Medical Products Virtual Public Meeting November 14, 2023 | 3:30-5pm (Eastern) How can FDA and other stakeholders better facilitate and support post-market…
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  • Monday, November 13, 2023
    FDA Deputy Commissioner Goes In-Depth About Human Foods Priorities, His Approach to Change - Food Safety Magazine
    On November 13, 2023, the Alliance for a Stronger FDA hosted a webinar with James "Jim" Jones, the recently appointed Deputy Commissioner for Human Foods at the U.S. Food and Drug Administration (FDA), during which he discussed his…
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  • Thursday, November 09, 2023
    Monday’s webinar with FDA’s Jim Jones is open to all - LexBlog
    An Alliance for a Stronger FDA webinar on  Monday, Nov. 13, will feature  Jim Jones,  FDA Deputy Commissioner for Human Foods. Alison Bodor of the American Frozen Foods Institute, and Thomas Gremillion of the Consumer Federation of America…
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  • Wednesday, November 08, 2023
    The FDA Is Still Not Tracking How Farms Use Antibiotics - Civil Eats
    When bacteria develop resistance to front-line antibiotics, health care professionals lose their ability to treat deadly infections, leading to more than 35,000 deaths annually in the U.S. and more than 1.2 million worldwide. Read more
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  • Wednesday, November 01, 2023
    (Mis)Trust in the Era of Information-Overload - Nutraceuticals World
    FDA Commissioner Robert Califf, MD, recently said the need to address misinformation is “probably the most difficult issue in my career.” Delivering accurate, understandable, and timely health information to the public, as well as to experts…
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  • Tuesday, October 31, 2023
    First CRISPR therapy one step closer to approval - POLITICO Prescription Pulse
    Expert advisers will consider today how two companies assessed potential risks with their proposed first-ever gene-editing treatment for sickle cell disease, a rare condition that disproportionately affects people of color. Read more
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  • Sunday, October 29, 2023
    King: Progress Implementing Reagan-Udall Suggestions - Tobacco Reporter Online
    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has made significant progress in addressing the recommendations made by an expert panel facilitated by the Reagan-Udall Foundation, CTP Director Brian King said in a recent …
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  • Thursday, October 26, 2023
    Strange Bedfellows: ‘FDA Foods Coalition’ Launches to Support FDA Redesign - Food Processing Online
    A broad and odd collection of groups today announced the launch of the FDA Foods Coalition, meant to support and lobby the food safety agency as it develops its planned Human Foods Program. Read more
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  • Wednesday, October 25, 2023
    Food industry optimistic on engagement with new FDA human foods leader - Agri Pulse
    Jim Jones, the FDA's newly designated deputy commissioner of human foods, sees partnering with food industry stakeholders as crucial to accomplishing the food safety goals of the agency. Read more
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  • Tuesday, October 24, 2023
    After Covid, some states see more TB cases - POLITICO Prescription Pulse
    The agency’s Center for Tobacco Products is hosting a two-day public meeting through today on best practices when asking the regulator to authorize new tobacco products — including e-cigarettes. Read more
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  • Monday, October 23, 2023
    Califf Provides Update on Front-of-Package Labeling - National Law Review
    On October 17, the FDA published “Catching Up with Califf: Advancing Nutrition, Healthy Food Options and Front-of-Package Labeling.”  Read more
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  • Tuesday, October 17, 2023
    Advancing Nutrition, Healthy Food Options and Front-of-Package Labeling - FDA Voices
    Last month was the one-year anniversary of the White House Conference and National Strategy on Hunger, Nutrition and Health. The FDA continues to make great progress on our nutrition efforts, which can help to combat the epidemic of diet-…
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  • Monday, October 16, 2023
    Dysfunction in Congress could put federal food safety programs at risk - Food Safety News
    The federal government machine has only enough quarters to keep food safety functioning for another month. And was it as simple as putting quarters in a machine to keep it running?   Read more
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  • Friday, October 06, 2023
    Trial Design, Treatment Options Spotlighted in Xylazine Conference - MedPageToday
    Longer observation periods following treatment and safety considerations for chronic and frequent users are among the many research issues about xylazine-laced fentanyl that need addressing, Rachel Wightman, MD, said at a meeting on mitigating risks from…
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  • Friday, October 06, 2023
    The FDA’s plan to tackle misinformation - POLITICO Prescription Pulse
    FDA Commissioner Robert Califf said Thursday that misinformation, what he sees as one of the biggest issues facing his agency’s many jurisdictions, needs an equally expansive, overlapping approach. Read more
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  • Thursday, October 05, 2023
    Reagan-Udall Foundation lays out methods for FDA to combat misinformation - Endpoints News
    The Reagan-Udall Foundation on Thursday published a wide-ranging report on how the FDA can combat misinformation, marking some progress on one of FDA Commissioner Robert Califf’s key goals for the agency. Read more
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  • Thursday, October 05, 2023
    Report: FDA needs to get ahead of misinformation - POLITICO Pro
    The FDA should treat communications as an integral part of the agency’s mission, better engaging the media and trusted messengers to convey science and policy information to combat misinformation upfront, an independent group supporting the agency …
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  • Thursday, October 05, 2023
    Virtual Public Meeting: Strategies for Improving Public Understanding of FDA-Regulated Products
    Strategies for Improving Public Understanding of FDA-Regulated Products Virtual Public Meeting
    Read More
  • Wednesday, October 04, 2023
    Public Meeting: Mitigating Risks from Human Xylazine Exposure
    Mitigating Risks from Human Xylazine Exposure Public Meeting: In-person and Virtual  October 4, 2023 | 9:15 am-5 pm (eastern) The Foundation partnered with the Food and Drug Administration (FDA) to host "Mitigating Risks from Human Xylazine…
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  • Tuesday, October 03, 2023
    Reagan-Udall Foundation To Propose FDA Rebuild Trust To Combat Misinformation - Inside Health Policy
    The Reagan-Udall Foundation is set to release a major new report Thursday (Oct. 5) that will suggest FDA combat health misinformation surrounding FDA-regulated products by rebuilding longstanding trust in the agency instead of reacting to issues case-by-…
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  • Sunday, October 01, 2023
    With fentanyl’s arrival, WA’s music scene turns to education, naloxone - Seattle Times
    Pinpoint pupils. Discoloration. Blue or gray lips. Clammy skin. Slow breathing. Loss of consciousness. Read more
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  • Friday, September 29, 2023
    Advancing Accurate Representation in Research Episode Four - Questions You Didn't Ask Podcast
    Read More
  • Tuesday, September 26, 2023
    New FDA administrator says he is ready to cooperate to restructure the agency - LexBlog
    The Food and Drug Administration’s first Deputy Commissioner for Human Foods, Jim Jones, started his work yesterday and sent the below letter to colleagues. Read more
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  • Tuesday, September 26, 2023
    FDA Roundup September 26
    On Friday, the FDA and the Reagan-Udall Foundation for the FDA announced a public meeting on October 4 titled, “Mitigating Risks from Human Xylazine Exposure”.  Read more
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  • Friday, September 22, 2023
    Another tool to fight RSV may be coming for parents- POLITICO Online
    The Reagan-Udall Foundation plans to release a commissioner-requested report on Oct. 5 — as long as the federal government doesn’t shut down — outlining how the FDA can more effectively combat misinformation, the group’s leader said this week. Read more
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  • Friday, September 22, 2023
    Advancing Accurate Representation in Research Part Three- Questions You Didn't Ask Podcast
    Research Director Carla Rodriguez Watson, PhD, MPH continues the RAISE conversation about race and ethnicity data in healthcare.  Listen to the podcast
    Read More
  • Friday, September 15, 2023
    Advancing Accurate Representation in Research Part Two - Questions You Didn't Ask Podcast
    The second in a series of podcasts on improving clinical trial access to diverse populations. The September 15 episode features FDA Foundation Research Director Carla Rodriguez-Watson, PhD, MPH as she, and others, discuss potential solutions.…
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  • Thursday, September 14, 2023
    Combining the ‘Ingredients’: FDA Reorganizes Human Foods Infrastructure Under a Single Leader - JD Supra
    In a sizable step toward reorganizing the Human Foods Program (HFP or Program) to rehaul the US Food and Drug Administration’s (FDA’s) current food infrastructure to better coordinate the agency’s regulation of food products, FDA announced the…
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  • Tuesday, September 12, 2023 - Wednesday, September 13, 2023
    Good Clinical Practice: Considerations for Trials with Pragmatic or Decentralized Features
    On September 12 and 13, the Foundation, in collaboration with the U.S. Food and Drug Administration, hosted a webinar to explore Good Clinical Practice Considerations for Trials with Pragmatic or Decentralized Features. We convened international experts…
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  • Monday, September 11, 2023
    The American people deserve a single food safety agency -Food Safety News
    Both of us have dedicated our careers to advancing food safety and protecting the public. We’ve both done so at the height of federal service, in academic settings, as well as within the private sector. That’s why we believe we’re well qualified to…
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  • Friday, September 08, 2023
    Advancing Accurate Representation in Research Part One- Questions You Didn't Ask Podcast
    Host Niasha Fray welcomes Carla Rodriguez-Watson, PhD, MPH, FDA Foundation Director of Research to discuss improving the collection and curation of race and ethnicity data in health care. They discuss challenges and explore solutions.…
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  • Wednesday, August 30, 2023
    Research Director Carla Rodriguez Watson and CEO Susan C. Winckler discuss RAISE on the OMHHE podcast
    On OMHHE’s latest podcast, FDA Foundation’s CEO, Susan Winckler, RPh, Esq. and Research Director, Carla Rodriguez-Watson, PhD, MPH, discuss the RAISE, a project to improve the capture and curation of race & ethnicity data in health care—and the…
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  • Wednesday, August 30, 2023
    FDA Issues Warning Letters to Three Infant Formula Manufacturers - Associated Press Online
    Today, the U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that the industry is producing infant formula under the…
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  • Thursday, August 24, 2023
    FDA Commissioner names EPA insider to agency’s top food safety post - Lex Blog
    EPA’s James “Jim” Jones was named Wednesday as the first FDA Deputy Commissioner for Human Foods.  In an expanded position, he will fill the voids left at the FDA by the February departure of Frank Yiannas, who was the Deputy Commission for the…
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  • Wednesday, August 23, 2023
    FDA Names First Deputy Commissioner for Proposed, Unified Human Foods Program - Associated Press
    Today, the U.S. Food and Drug Administration is announcing the selection of James “Jim” Jones to serve as the first Deputy Commissioner for Human Foods. The new executive position will lead the charge in setting and advancing priorities for a proposed…
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  • Wednesday, August 23, 2023
    FDA taps new Human Foods Program head after baby formula crisis - Roll Call
    The Food and Drug Administration on Wednesday announced the selection of its first deputy commissioner for human foods — part of an effort to reorganize the agency’s oversight of food safety after contaminated baby formula caused major shortages…
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  • Tuesday, August 15, 2023
    Reagan-Udall Foundation for the FDA Names 2023-24 Fellow in Regulatory Science, Innovation, and Health Equity
    (August 15, 2023) The Reagan-Udall Foundation for the FDA has selected Kendra Getaw, PharmD, as its 2023-24 Fellow in Regulatory Science, Innovation, and Health Equity. Her year-long role, which began July 2023, includes activities across the…
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  • Monday, August 07, 2023
    FDA seeks input on antimicrobial use data collection framework - Beef Magazine
    The U.S. Food and Drug Administration (FDA) has opened a docket to seek public comment on a report outlining a potential framework for establishing a public-private partnership (PPP) to collect and analyze antimicrobial use (AMU) data from food…
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  • Wednesday, August 02, 2023
    FDA requests public input on analyzing antimicrobial use in animals - Veterinarian's Money Digest
    Officials with the FDA are seeking feedback from the public on a report1 outlining a potential framework for establishing a public-private partnership (PPP) to collect and analyze antimicrobial use (AMU) data from food-producing animals. The report…
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  • Wednesday, August 02, 2023
    Reagan-Udall Foundation Lays Groundwork for Public-Private Partnership to Track AMU in Food-Producing Animals - Food Safety Magazine
    The Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) has published a new report, titled, Establishing a Draft Framework for a Public-Private Partnership to Support the Tracking of Antimicrobial Use in Food-Producing…
    Read More
  • Tuesday, August 01, 2023
    FDA Touts “Significant Strides” in Addressing Reagan-Udall Report but Acknowledges More Work Remains - LexBlog
    On June 29, Dr. Brian King, director of the Center for Tobacco Products (CTP) at the FDA, issued an update on CTP’s efforts to address the 15 recommendations outlined in a report by an independent expert panel facilitated by the…
    Read More
  • Monday, July 24, 2023
    FDA Head Robert Califf Battles Misinformation — Sometimes With Fuzzy Facts - Kaiser Health News
    Read More
  • Friday, July 21, 2023
    Gene Therapies: Hopes, Hurdles, and AI - POLITICO
    Experts told our Robert King at POLITICO’s Next Generation of Health Care Therapies event Thursday that they’re excited about the potential for artificial intelligence to help develop and test gene therapies to treat rare diseases. Read more
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  • Friday, July 21, 2023
    CTP Invites Input on Strategic Plan - Tobacco Reporter
    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) will hold a virtual listening session on Aug. 22 to give the public an opportunity to comment on its five-year plan it developed to advance its mission.
    Read More
  • Tuesday, July 18, 2023
    FDA Provides Update on Reagan-Udall Tobacco Panel - Convenience Store Decisions
    The administration summarized its progress and next steps following the evaluation from the expert panel regarding the FDA's tobacco program. Read more
    Read More
  • Monday, July 17, 2023
    FDA Proposes Reorg; Industry Reacts to Impact on Dietary Supplements - Whole Foods Magazine
    The U.S. Food and Drug Administration (FDA) recently provided an update on its proposal to create a unified Human Foods Program (HFP). This reorganization includes a new model for the Office of Regulatory Affairs (ORA).  Read more
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  • Thursday, July 13, 2023
    Facilitating Review of Real-World Data Studies: The Oncology QCARD Initiative - Healthcare Now Radio
    Expanding ways to generate evidence can lead to an array of benefits for medical product development, including more diverse patient representation and the potential to expedite the availability of safe and effective therapies. As data sources outside of…
    Read More
  • Wednesday, July 12, 2023
    US FDA’s Office Of Regulatory Affairs To Focus On Investigations, Inspections And Imports - Pink Sheet
    ORA to shed more responsibilities as the FDA focuses the likely-to-be renamed field organization more on inspections while revamping the agency's Human Food Program. Read more
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  • Monday, July 10, 2023
    FDA takes steps to decrease barriers for overdose reversal agents with Dr. Marta Sokolowska - Q&A with FDA Podcast
    Welcome to another episode of our podcast series, “Q&A with FDA”, from the FDA’s Division of Drug Information, where we answer some of the most frequently asked questions that we’ve received. In a previous episode, we discussed FDA’s Overdose…
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  • Thursday, July 06, 2023
    FDA proposes relocation of Office of Dietary Supplement Programs, industry reacts - Food Navigator USA
    The dietary supplement industry is expressing concern over a proposed update to a Food and Drug Administration (FDA) reorganization that would relocate the current Office of Dietary Supplement Programs (ODSP) to a new office under its “Risk Management…
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  • Wednesday, July 05, 2023
    CHPA responds to FDA proposal for a Unified Human Foods program - Drugstore News
    The Food and Drug Administration has provided an update on its proposal to create a unified Human Foods Program, which includes a new model for the Office of Regulatory Affairs. Scott Melville, president of the Consumer Healthcare Products Association,…
    Read More
  • Wednesday, July 05, 2023
    FDA Announces Revised Plans for Human Foods Program - JD Supra
    The U.S.
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  • Thursday, June 29, 2023
    CTP Reports Progress on Reagan-Udall Review - Tobacco Reporter Online
    Brian King, director of U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), published a statement summarizing the CTP’s progress in addressing the recommendations from the Reagan-Udall evaluation.
    Read More
  • Thursday, June 29, 2023
    CTP’s Progress Addressing Recommendations from the Reagan-Udall Evaluation -Statement from CTP Director-
    In February, I announced the Center for Tobacco Product’s (CTP) “all-center” approach to responding to the evaluation of our center by an independent expert panel facilitated by the Reagan-Udall Foundation (RUF), including our plans to address the 15…
    Read More
  • Wednesday, June 28, 2023
    FDA rethinks reorganization, allocates more authority to proposed deputy commissioner for human foods - Food Navigator
    Heeding the advice of food industry leaders and public safety advocates, FDA has “significantly broadened” the proposed responsibilities and oversight of the planned Human Foods Program under a larger reorganization that seeks to address shortcomings…
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  • Wednesday, June 21, 2023
    ChatGPT Poses New Regulatory Questions for FDA, Medical Industry Bloomberg Law
    Large language models popularized by ChatGPT show up in nearly all of FDA Commissioner Robert Califf’s speeches lately, as he makes clear he wants to get ahead of regulating the disruptive technology. Read more
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  • Thursday, June 15, 2023
    House committee directs FDA Commissioner to unify FDA food programs with a clear chain of command - Food Safety News
    An appropriations bill from a committee in the U.S. House of Representatives would direct the FDA to unify its food program under one person. The move echoes the sentiment from a House committee, former FDA leaders, and experts in the field of food…
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  • Thursday, June 15, 2023
    RAISE Public Meeting: Lessons Learned & Practical Applications for the Future
    RAISE: Lessons Learned & Practical Applications for the Future June 15, 2023 2-4 pm ET  
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  • Thursday, June 01, 2023
    Staking a Claim? - The Tobacco Reporter
    It seemed an excellent test case for a new system. After role-playing a U.S. Food and Drug Administration Tobacco Products Scientific Advisory Committee (TPSAC) member, listening to Altria’s presenters rehearse their pitch, that was my impression. Read…
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  • Thursday, June 01, 2023
    RAISE: Reactions to Barriers, Facilitators, and Proposed Solutions
    RAISE: Reactions to Barriers, Facilitators, and Proposed Solutions Thursday, June 1, 2023 2-3 PM ET
    Read More
  • Wednesday, May 31, 2023
    FDA Commissioner Laments Lawsuits - Tobacco Reporter
    U.S. Food and Drug Administration Commissioner Robert Califf has lamented the FDA’s ongoing tobacco industry litigation following the agency’s attempt to regulate e-cigarettes, according to Politico. The FDA is facing over 40 lawsuits from companies…
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  • Sunday, May 28, 2023
    Supplemental Filings: Califf Discusses Revolving Door; Poll Examines Public Trust In FDA Approvals - Pink Sheet
    Commissioner Robert Califf continues to raise attention about what he terms the “revolving door for lawyers,” between the FDA and industry. Agency staff leaving for jobs in the private sector is nothing new, but Califf mentioned during a speech at the…
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  • Thursday, May 25, 2023
    Califf Plans US FDA, NIH Collaboration On Postmarket Evidence Generation - Pink Sheet
    US Food and Drug Administration Commissioner Robert Califf’s evidence generation enhancement plans will include the National Institutes of Health, assuming that agency’s new leader takes office. Read more
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  • Wednesday, May 24, 2023
    2023 Annual Public Meeting
      Each year, the Reagan-Udall Foundation for the FDA conducts an Annual Public Meeting of its Board of Directors to share information about our activities in support of the U.S. Food and Drug Administration. By bringing together a variety…
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  • Tuesday, May 23, 2023
    Food safety groups pitch congressional leaders on the inside game- LexBlog
    Eleven organizations that work closely with the Food and Drug Administration are asking bipartisan congressional leaders to work with them on “several pressing food safety issues this year.” Read more
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  • Tuesday, May 23, 2023
    Carla Rodriguez-Watson, PhD, MPH appears on Five3One Podcast
    The FDA Foundation's Director of Research, Carla Rodriguez-Watson, PhD, MPH, discusses designing clinical studies for diversity and inclusivity in patient selection. Listen to the podcast
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  • Thursday, May 18, 2023
    RAISE: Advanced Analytics: Interim Solutions When Race & Ethnicity are Missing
    RAISE: Advanced Analytics: Interim Solutions When Race & Ethnicity are Missing Thursday, May 18, 2023 2-3 PM ET  
    Read More
  • Tuesday, May 16, 2023
    ‘Whose Line Is It Anyway’: The Biden edition - The Washington Times
    Remember the comedy program “Whose Line Is It Anyway,” described by host Drew Carey as the show “where everything’s made up, and the points don’t matter”? Well, the spinoff has now taken shape in Washington, with President Biden at the helm. Read more
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  • Tuesday, May 16, 2023
    The impact of FDA’s new blood donation guidelines - POLITICO Prescription Pulse
    The FDA’s independent advisory committee on tobacco products will meet this week for the first time since February 2020.  Read more 
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  • Wednesday, May 10, 2023
    2023 Issues, Predictions & Trend Forecast For Food: The FDA, FTC And Food Legislation - Forbes Online
    We need to talk about the FDA. In December of 2022 the Reagan-Udall Foundation published their external review of the FDA’s food program. It is important to point out that Regan-Udall is actually the FDA’s Foundation – so if anything, their scathing and…
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  • Wednesday, May 10, 2023
    A Critical Evaluation of FDA’s Center for Tobacco Products - Lex Blog
    In July 2022, the Food and Drug Administration (FDA) Commissioner, Dr. Robert Califf, released a public statement saying the agency “has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s…
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  • Wednesday, May 10, 2023 - Thursday, May 11, 2023
    Considerations for Buprenorphine Initiation and Maintenance Care
    Considerations for Buprenorphine Initiation and Maintenance Care Wednesday, May 10, 2023, 1 – 4:45 pm ET Thursday, May 11, 2023,  1 – 4:30 pm ET  
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  • Thursday, May 04, 2023
    RAISE: Considerations in the Measurement of Race and Ethnicity, Downstream Effects, and Novel Methods to Address the Issues
    RAISE: Considerations in the Measurement of Race and Ethnicity, Downstream Effects, and Novel Methods to Address the Issues Thursday, May 4, 2023 2-3 PM ET
    Read More
  • Wednesday, April 26, 2023
    Focus on Harm Reduction - Tobacco Reporter Online
    In the run-up to the 10th Conference of the Parties to the Framework Convention on Tobacco Control in Panama (COP10) this November, public health professionals, industry representatives and policy experts on April 25 shared their insights into issues…
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  • Friday, April 21, 2023
    Op-Ed: Biden’s Cancer Moonshot will fail without reform of the FDA - The Center Square
    The Biden Administration’s much-trumpeted Cancer Moonshot campaign was launched just over a year ago with the goal of reducing cancer rates by more than 50 percent in the next 25 years. However, considering that The White House has identified almost a…
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  • Thursday, April 20, 2023
    RAISE: Missingness, Misclassification, and Measurement Bias in Race and Ethnicity
    RAISE: Missingness, Misclassification, and Measurement Bias in Race and Ethnicity Thursday, April 20, 2023 2-3 PM ET
    Read More
  • Thursday, April 13, 2023
    Real-World Evidence Webinar Series: Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Draft Guidance for Industry
    Real-World Evidence Webinar Series: Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Draft Guidance for Industry  April 13, 2023, 2-3 PM ET  
    Read More
  • Wednesday, April 12, 2023
    We need a way to tell useful mental health tech from digital snake oil - STAT
    Prior to the early 20th century, America had no regulation of medications or food additives. Formaldehyde was used to preserve meat, morphine was included in infant “soothing syrups,” and marketing, not science, drove the promotion of tonics and…
    Read More
  • Thursday, April 06, 2023
    RAISE: Technical Challenges in the Transfer of Information
    RAISE: Technical Challenges in the Transfer of Information  Thursday, April 6, 2023 2-3 PM ET 
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  • Friday, March 31, 2023
    What is Narcan? The opioid overdose spray, explained. - Vox
    A long-sought tool in the fight against America’s opioid crisis is becoming available later this year: Narcan, the nasal spray that can stop opioid overdoses as they are happening, will finally be sold over the counter. Read more
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  • Wednesday, March 29, 2023
    FDA Approves Opioid Overdose Treatment Narcan for Over-the-Counter Sales - Rolling Stone
    AN OVER-THE-COUNTER NASAL spray version of Narcan, the medication used to reverse the effects of an opioid overdose, was officially approved by the Food and Drug Administration today, March 29.  Read more
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  • Wednesday, March 29, 2023
    Drug overdose antidote Narcan goes over-the-counter - The Washington Post
    Narcan, the lifesaving nasal spray that reverses opioid overdoses, has been approved for purchase without a prescription, the Food and Drug Administration announced on Wednesday. Read more
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  • Tuesday, March 28, 2023
    Over-the-Counter Narcan Could Save More Lives. But Price and Stigma Are Obstacles. - New York Times
    If Narcan, the nasal spray that saves lives by reversing opioid overdoses, receives approval to be sold over the counter, public health officials hope the palm-size plunger could one day become as commonplace as a kitchen fire extinguisher. Read more
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  • Monday, March 27, 2023
    Biden officials flood the Hill - POLITICO
    FDA ON THE HILL: Califf on Wednesday will testify before the House Appropriations Committee on Biden’s fiscal 2024 budget. Read more
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  • Wednesday, March 22, 2023
    Generating evidence for racial and ethnic minorities during development of oncologic therapeutics - Regulatory Focus
    Discussions regarding diversity, equity, and inclusion in healthcare and clinical research have been ongoing for decades. However, the COVID-19 global pandemic brought about a new focus on this issue.
    Read More
  • Wednesday, March 22, 2023
    Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Science and Application Review Task Force - LexBlog
    There is a common refrain that appears throughout the Reagan-Udall Foundation report on the Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA) — lack of transparency.
    Read More
  • Thursday, March 16, 2023
    Even over the counter, Narcan may be too costly to reach many drug users - Washington Post
    Before month’s end, federal regulators are poised to allow over-the-counter sale of a nasal spray that reverses the potentially lethal effects of an opioid overdose. But groups that work to reduce the toll of drugs on the streets have one question: Will…
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  • Thursday, March 16, 2023
    Coalition wants an audience with the Senate committee to discuss FDA leadership - LexBlog
    A coalition of consumer and industry groups is seeking a meeting with a Senate committee regarding the head of the FDA and his response to a recent report calling for a reorganization of the agency.
    Read More
  • Thursday, March 16, 2023
    RAISE: Creating Safe Space II: Capturing Race and Ethnicity Data
    RAISE: Creating Safe Space II: Capturing Race and Ethnicity Data Thursday, March 16, 2023 2-3 PM ET 
    Read More
  • Wednesday, March 08, 2023 - Thursday, March 09, 2023
    Understanding Fatal Overdoses to Inform Product Development and Public Health Interventions to Manage Overdose
    Understanding Fatal Overdoses to Inform Product Development and Public Health Interventions to Manage Overdose March 8, 1-4:45 PM ET  March 9, 1-4:45 PM ET    The Reagan-Udall Foundation for the FDA, in partnership with the U.S.…
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  • Friday, March 03, 2023
    The FDA’s CTP Review Uncovers Multiple Issues - The Vaping Post
    It is no secret that the FDA has been under scrutiny for multiple reasons related to the authorization of safer nicotine alternative products. Last Summer the agency was heavily criticised by Senators Dick Durbin (D-Ill.) and Susan Collins (R-Maine).…
    Read More
  • Friday, March 03, 2023
    It’s time for a Department of Food and Nutrition - Food Safety News
    The failures of the federal Food and Drug Administration (FDA) have been in plain view since at least early 2022. At that point the public saw the FDA’s  scandalous neglect of Abbott Nutrition’s contaminated infant formula — which was reported to…
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  • Thursday, March 02, 2023
    RAISE: Creating Safe Space I: Reporting Race 101
    RAISE: Creating Safe Space I: Reporting Race 101 Thursday, March 2, 2023 2-3 PM ET  
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  • Wednesday, March 01, 2023
    The FDA plan: The morning after the morning after - Food Safety News
    New York Times columnist Thomas Friedman once wrote; “Everything really important happens the morning after the morning after…” In short, focus on what really changes, not what is said will change. That is a good lesson for the White House and…
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  • Wednesday, March 01, 2023
    FDA’s update for new Human Foods Program falls short of industry expectations - Food Navigator
    Even as FDA kicks off a search for a deputy commissioner for its proposed Human Foods Program who it says will have a “clear line of authority over” all human food safety and nutrition programs, industry stakeholders worry agency is choosing a “business…
    Read More
  • Tuesday, February 28, 2023
    FDA Provides Update on Proposed Human Foods Program and Office of Regulatory Affairs Restructuring - FDA Statement
    Today, the U.S. Food and Drug Administration announced that it has begun a national search for a new Deputy Commissioner for Human Foods and is providing an update on last month’s proposed restructuring of the agency’s Human Foods…
    Read More
  • Friday, February 24, 2023
    An All-Center Approach: CTP’s Response to the Reagan-Udall Foundation Evaluation Report - FDA Statement
    In September 2022, an independent expert panel facilitated by the Reagan-Udall Foundation began an operational evaluation of the Center for Tobacco Products (CTP) at the request of Food and Drug Administration Commissioner, Dr. Robert Califf.
    Read More
  • Friday, February 24, 2023
    FDA says there’s ‘a lot more work to come’ to improve the way it regulates tobacco products - CNN
    On Friday, the US Food and Drug Administration’s Center for Tobacco Products announced steps it would take to do a better job regulating tobacco products.
    Read More
  • Thursday, February 23, 2023
    How biomarkers can support regulatory rare disease pathways - BioNews
    On February 21, the Biotechnology Innovation Organization’s (BIO) soon-to-be CEO, John F. Crowley, joined an event about biomarkers and rare disease regulatory pathways, hosted by the Reagan-Udall Foundation for the Food and Drug Administration in…
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  • Wednesday, February 22, 2023
    Highlighting Major Issues Critical to FDA Across Our Diverse Agency After One Year Back - FDA Statement
    This week marks my one-year anniversary as the 25th Commissioner for Food and Drugs. I have been proud to represent the U.S. Food and Drug Administration and its talented and hard-working staff in these extraordinary times.  Read more
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  • Thursday, February 16, 2023
    RAISE: Collecting Better Data II: System Infrastructure
    RAISE: Collecting Better Data II: System Infrastructure Thursday, February 16, 2023 2-3 PM ET    
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  • Thursday, February 09, 2023
    3 ways the FDA’s restructuring plan could impact pharma - PharmaVoice
    For years, pharmaceutical industry officials have argued that splitting the FDA into two agencies — one that regulates medical products, and one that regulates food — would improve efficiency. Read more
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  • Tuesday, February 07, 2023
    Reagan-Udall Foundation for the FDA Announces New Board Leadership, Members
    (February 7, 2023) The Reagan-Udall Foundation for the FDA (FDA Foundation) has announced new officers and members of its Board of Directors.  Richard L. Schilsky, MD, FACP, FSCT, FASCO, has been elected to a three-year term as Chair of the FDA…
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  • Thursday, February 02, 2023
    RAISE: Collecting Better Data: Incentives, Framework, and Mission
    RAISE: Collecting Better Data: Incentives, Framework, and Mission Thursday, February 2, 2023 2-3 PM ET   Incomplete and inconsistent capture of information about race and ethnicity in real-world data (RWD) limits a full understanding of the…
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  • Wednesday, February 01, 2023
    FDA to overhaul its food division in wake of baby formula crisis - The Washington Post
    The Food and Drug Administration will create a senior position to oversee food safety and nutrition after a series of foodborne-illness crises, including a nationwide baby formula shortage, exposed major flaws in the agency’s…
    Read More
  • Tuesday, January 31, 2023
    Following criticism, FDA proposes redesign of its human food program - CNN International
      The head of the US Food and Drug Administration proposed sweeping changes to the agency’s food safety programs Tuesday in order to protect the US food supply and promote better nutrition. Read more
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  • Thursday, January 26, 2023
    Real-World Accelerator to Improve the Standard of collection and curation of race and Ethnicity data in healthcare (RAISE)
    Improving the Collection and Curation of Race and Ethnicity Data in Health Care Thursday, January 26, 2023 2-4 PM ET   
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  • Monday, January 23, 2023
    FDA needs a new approach to e-cigarettes and other safer alternatives to traditional cigarettes - The Reason Foundation
    Last month, the Reagan-Udall Foundation delivered a damning review of the Food and Drug Administration’s (FDA) performance as a tobacco regulator.     Read more
    Read More
  • Tuesday, January 10, 2023
    Q&A with FDA Commissioner Robert Califf on baby formula, food safety - The Washington Post
    The baby formula crisis of 2022 triggered intense soul-searching at the U.S. Food and Drug Administration. What went wrong? How can the government prevent similar disasters from happening again? Read more
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  • Tuesday, January 10, 2023
    For the nation’s health, break up the Food and Drug Administration - The Washington Post
    The Food and Drug Administration last year failed repeatedly to keep the nation’s babies safe from tainted formula.
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  • Monday, January 09, 2023
    Reagan-Udall Foundation Recommends Improvements to the FDA’s Center for Tobacco Products - JD Supra
    The Reagan-Udall Foundation, an independent nonprofit created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety”…
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  • Wednesday, January 04, 2023
    Congress earmarks funds to unify FDA's food program, enhance safety & inspections - Food Navigator
    Within the $1.7 trillion spending bill signed by President Joe Biden late last week is a substantial increase in funding to boost food safety activities and “infrastructure investments” at FDA, including directions to “strongly consider” the Reagan-Udall…
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  • Saturday, December 31, 2022
    ‘I know firsthand they failed’: Parents decry lack of FDA action on infant formula safety - POLITICO Special Report
    When Kelly Knight gave birth to her son, Ryker, she was thrilled — and carrying the memory of the two babies she’d previously lost at nearly full term. Read more
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  • Thursday, December 29, 2022
    The Biggest Tobacco Harm Reduction Battles to Come in 2023 - FILTER Magazine
      United States tobacco control did not have an easy 2022. So much turmoil has come and gone this past year that even the most dedicated harm reductionists and critics struggled to keep up at one point or another, as separate events blurred into…
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  • Friday, December 23, 2022
    Williams: FDA needs modernization, not more $$ - The Boston Herald
    A long-awaited review of the Food and Drug Administration’s Human Foods Program, partly funded by the FDA, is out. The conclusion from the Reagan-Udall Foundation is that the FDA is a great deal for consumers and would…
    Read More
  • Tuesday, December 20, 2022
    FDA center struggling to regulate tobacco products, review finds - The Hill
    The staff at the Food and Drug Administration’s tobacco division are overwhelmed, leading to a division that is too reactionary and has “struggled to function as a regulator,” according to an outside report.  Read more
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  • Tuesday, December 20, 2022
    Ball in FDA's Court as Official Review Cites Its Chaos, Opacity Over Vapes - Filter Magazine
    On December 19, the Reagan-Udall Foundation, an independent nonprofit tasked by Congress to help modernize the Food and Drug Administration (FDA), released a commissioned report on the agency’s Center for Tobacco Products (CTP).  Read more
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  • Tuesday, December 20, 2022
    FDA's tobacco arm "struggled to function as a regulator": report - Axios
    The arm of the FDA that oversees tobacco products has "struggled to function as a regulator" and has been "forced to operate primarily in a reactive mode" a report released Monday by the Reagan-Udall Foundation found. Read more
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  • Monday, December 19, 2022
    FDA Provides Update on External Evaluation to Strengthen Agency’s Tobacco Program - FDA Statement
    Earlier this year, I commissioned an external evaluation of the U.S. Food and Drug Administration’s Tobacco Program, to be conducted by an external expert panel facilitated by the Reagan-Udall Foundation, led by former FDA Chief of Staff Lauren…
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  • Monday, December 19, 2022
    FDA Provides Update on External Evaluation to Strengthen Agency’s Tobacco Program - FDA News Service
    Earlier this year, I commissioned an external evaluationExternal Link Disclaimer of the U.S. Food and Drug Administration’s Tobacco Program, to be conducted by an external expert panel facilitated by the Reagan-Udall Foundation, led by former…
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  • Monday, December 19, 2022
    Independent panel finds lack of transparency, ineffective enforcement hinders FDA's tobacco operations - POLITICO
    An independent panel composed of former FDA and Centers for Medicare and Medicaid Services officials is recommending changes to the FDA’s tobacco regulatory operation to more effectively regulate new tobacco products. Read more
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  • Monday, December 19, 2022
    Panel warns FDA’s beleaguered tobacco unit lacks direction - The Associated Press
    The lack of clear direction and priorities at the U.S. Food and Drug Administration’s tobacco division has hampered its ability to regulate electronic cigarettes and other products, according to an expert panel assembled to examine problems at the agency…
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  • Monday, December 19, 2022
    Major effort needed to remove illegal vaping products, review finds - The Washington Post
    An independent review of the Food and Drug Administration’s tobacco regulators described them as overwhelmed, reactive and fatigued by an oppressive workload involving e-cigarettes and called for a major effort, by several parts of the Biden…
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  • Monday, December 19, 2022
    Expert Panel Submits Operational Evaluation of FDA’s Tobacco Program to Commissioner
    (December 19, 2022) The Independent Expert Panel for Tobacco today submitted its recommendations to Commissioner Robert Califf at the U.S. Food and Drug Administration. The Operational Evaluation of Certain Components of FDA’s Tobacco Program was…
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  • Friday, December 16, 2022
    'Constant Turmoil' at FDA Makes Our Food Less Safe - MedPage Today
    Americans take the safety of our food for granted. But it's not safe by accident. Our food is safe because of laws that ensure food companies and farmers take steps to keep pathogens out of our food. And the enforcement of these laws depends on the…
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  • Thursday, December 15, 2022
    Reagan-Udall Foundation for the FDA Launches Real-World Data Initiative to Address Disparities
    (December 15, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) is launching the Real-world Accelerator to Improve the Standard of collection and curation of race and Ethnicity data in health care (RAISE). The initiative, funded by the Food…
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  • Friday, December 09, 2022
    FDA’s food safety failings flagged in independent report as agency reviews internal systems and budget limitations - Food Industry Today
    In scrutiny of the US Food and Drug Administration’s (FDA) Human Food Program, an independent expert panel is arguing that the agency “lacks the resources and authority to do what is expected to do – ensure the safety and availability of food on the…
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  • Friday, December 09, 2022
    Things are not Okay at FDA - Food Fix
    Last summer, when FDA Commissioner Robert Califf announced he’d asked the Reagan-Udall Foundation to review the agency’s foods program, the response around Washington wasn’t exactly positive.  Read more
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  • Thursday, December 08, 2022
    Food For Thought On US FDA Reforms - Pink Sheet
    An independent review of the US FDA’s food regulatory programs could renew a debate over splitting FDA into two agencies. Read more
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  • Thursday, December 08, 2022
    Report Recommends Overhaul Of FDA Food Program, Separate Food Agency - Inside Health Policy
    FDA and Congress need to overhaul the agency’s food program, including by making structural changes, such as establishing a separate food-focused agency under HHS, and appointing an overarching head of the food program to remedy issues with work culture…
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  • Thursday, December 08, 2022
    Report: To Ensure Food Safety, FDA Needs Big Changes - Food Processing Online
    The FDA needs to be overhauled to make food safety enforcement more effective, according to a report by an outside agency. The report from the Reagan-Udall Foundation recommended sweeping changes, including the establishment of a single individual…
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  • Tuesday, December 06, 2022
    FDA Provides Update on External Evaluation to Strengthen Agency’s Human Foods Program -FDA Statement
    In July, I commissioned an external evaluation of the U.S. Food and Drug Administration’s Human Foods Program, including the Office of Food Policy and Response (OFPR), the Center for Food Safety and Applied Nutrition (CFSAN), as well as relevant parts of…
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  • Tuesday, December 06, 2022
    2022 Innovations in Regulatory Science Awards Highlights
       
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  • Tuesday, December 06, 2022
    ‘Constant turmoil’ at FDA’s food regulatory agency, report says- POLITICO
    The Food and Drug Administration’s Human Foods Program lacks leadership and mission clarity, leading to slow decision-making and weak regulation of foodborne illness, according to a highly-anticipated, independent report on the FDA’s Human…
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  • Tuesday, December 06, 2022
    FDA's Food Safety Program Needs a Revamp: Panel- US News and World Report
    The Reagan-Udall Foundation, a group with close ties to the FDA, released a 51-page report Tuesday noting the need for a clear mission in the program and more urgency to prevent illness outbreaks. FDA Commissioner Dr. Robert Califf first …
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  • Tuesday, December 06, 2022
    F.D.A. Report Faults Agency’s Food Unit for Leaderless Dysfunction- New York Times
    The Food and Drug Administration’s food division has no clear leadership, avoids bold policy or enforcement actions, and fosters a culture that doesn’t adequately protect public health, according to a report issued on Tuesday by an agency-…
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  • Tuesday, December 06, 2022
    In wake of baby formula crisis, highly critical report recommends major food safety changes at FDA - CNN
    To help prevent outbreaks of food-related illness and problems like the formula shortage that left many parents in the US without adequate access to food for their babies, the US Food and Drug Administration needs a clearer mission and a different kind…
    Read More
  • Tuesday, December 06, 2022
    Expert Panel Completes Operational Evaluation of FDA’s Human Foods Program
    (December 6, 2022) Today, the Independent Expert Panel for Foods submitted its Operational Evaluation of FDA’s Human Foods Program to Dr. Robert Califf, Commissioner for Food and Drugs. The evaluation and report were facilitated by the Reagan-Udall…
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  • Tuesday, December 06, 2022
    2022 Innovations in Regulatory Science Awards
    Each year, the Reagan-Udall Foundation for the FDA brings the regulatory science community together to recognize the leadership, scientific breakthroughs, and unwavering advocacy that helps safeguard America’s public health. …
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  • Friday, December 02, 2022
    Reagan-Udall Foundation for the FDA Releases Snapshot 2022: A Changing Environment for FDA-Regulated Consumer Products
    (December 2, 2022) Today the Reagan-Udall Foundation for the FDA (FDA Foundation) announces the release of “Snapshot 2022: A Changing Environment for FDA-Regulated Consumer Products.” This report outlines how the COVID-19 pandemic, and the prevalence of…
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  • Monday, November 14, 2022
    Fundamental Flaws of Tobacco Control Act—and FDA’s Implementation - Filter Magazine
      When Congress passed the the Tobacco Control Act in 2009, it amended the federal Food, Drug, and Cosmetic Act to give the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution and marketing of tobacco products…
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  • Tuesday, November 08, 2022
    Advocacy Group Suggests FDA Reforms - The Tobacco Reporter
    The U.S. Food and Drug Administration has “significantly and substantially failed” to fulfill its congressional mandate to protect the public health, Americans for Tax Reform (ATR) told the Reagan-Udall Foundation in a letter. Read more
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  • Friday, November 04, 2022
    Why Most Everyone Thinks FDA Needs a Real Shakeup -Food Fix
    There are no shortage of battles, or even just sharp disagreements, over how food and agriculture policy should work. At times, it can get downright ugly. Read more
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  • Thursday, November 03, 2022
    Expanded Access Postings Not Promotional, Unless Done In ‘Promotional Context,’ US FDA Says - Pink Sheet
    Updated guidance on expanded access program clarifies that sponsors do not risk enforcement for off-label promotion if they post investigational drug expanded access policies, although that fear already may have subsided. Read more
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  • Tuesday, November 01, 2022
    Early Takeaways from Comments to Reagan-Udall's Expert Panel - POLITICO's Prescription Pulse
    As the Reagan-Udall Foundation undertakes its review of the FDA’s tobacco program, a number of legal, industry and public health experts are presenting the expert panel with written and oral comments about the major issues they see with the Center for…
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  • Monday, October 31, 2022
    Comments in FDA Assessment Suggest Agency in Disarray - Tobacco Reporter
    The U.S. Food and Drug Administration is in disarray and influenced by outside forces rather than scientific research, according to several comments submitted to the Reagan-Udall assessment of the performance of the FDA’s Center for Tobacco Products…
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  • Friday, October 28, 2022
    Regulatory Science, Innovation, and Health Equity Fellowship Established by Reagan-Udall Foundation for the FDA
    (October 28, 2022) The Reagan-Udall Foundation for the FDA is pleased to announce the launch of its Regulatory Science, Innovation, and Health Equity Fellowship Program. Increasing diversity in regulatory science serves to bring varied perspectives into…
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  • Friday, October 28, 2022
    Robert Temple, Medidata, George Vradenburg to be Recognized with Innovations in Regulatory Science Awards
    (October 27, 2022) The Reagan-Udall Foundation for the FDA will present 2022 Innovations in Regulatory Science Awards to Robert Temple, MD; Medidata; and George Vradenburg on December 6 at the Mayflower Hotel in Washington, DC. The awards …
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  • Tuesday, October 25, 2022
    FDA panel vote highlights accelerated approval concerns - POLITICO's Prescription Pulse
    TOBACCO PROGRAM REVIEW PANEL ENTERS DAY 3 OF LISTENING SESSIONS — The five-person expert panel tasked with evaluating the FDA’s tobacco regulatory program will embark on its final listening sessions from industry, legal and public health…
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  • Thursday, October 20, 2022
    COVID-19 Evidence Accelerator: What We've Learned, Where We're Headed
    In the midst of a global pandemic, the Reagan-Udall Foundation for the FDA, along with Friends of Cancer Research, created an unprecedented regulatory science collaborative to share real-world data and to generate innovative responses on how to deal with…
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  • Wednesday, October 19, 2022
    FDA panel that reviews food programs hears from interested parties- Industry Update
    Members of the Food and Drug Administration’s food program evaluation panel have a big job as they develop recommendations for FDA guidance. At a public meeting last month and in the hundreds of comments received through the online portal …
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  • Thursday, October 13, 2022
    Stakeholder Input Sought in Evaluation of FDA Tobacco Program
    (October 13, 2022) The Reagan-Udall Foundation today announced a series of upcoming virtual meetings and opened a Stakeholder Portal to solicit input for the Independent Expert Panel’s evaluation of certain portions of FDA’s tobacco program. 
    Read More
  • Saturday, October 08, 2022
    Coalition asks review panel to consider food leader for upper echelon at FDA - Food Safety News
    Editor’s note: This is a letter sent by a large coalition of consumer and industry groups to Jane Henney, the chair of the Independent Expert Panel – FDA Human Foods Program of the Reagan-Udall Foundation, that is charged with investigating…
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  • Wednesday, October 05, 2022
    FDA’s Yiannas: On the road toward a new era in food safety-Agri-Pulse
    Anyone who has heard Frank Yiannas speak has probably heard his “mango” story. It dates back to his time working for the world’s largest retailer and prior to joining the Food and Drug Administration in 2018 as deputy commissioner for food policy and…
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  • Tuesday, October 04, 2022
    The role of pharmacists in increasing patient access to ‘compassionate use’ programmes – The Pharmaceutical Journal-PhaMed
    During the COVID-19 pandemic, as healthcare systems sought ways to better prevent, treat and manage a previously unseen infection, rapid access to promising novel investigational therapies based on emerging scientific evidence from clinical trials was…
    Read More
  • Saturday, October 01, 2022
    FDA Continues Important Work on Substance Use and Overdose Prevention Efforts-EIN Presswire
    Overdose prevention, reduction in opioid and other substance use disorders (SUD), and effective treatment and support for those with SUD are key priorities for the U.S. Food and Drug Administration and personally for me as Commissioner. Read more
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  • Friday, September 30, 2022
    Food safety experts give recommendations to panel charged with reviewing FDA- Food Safety News
    Yesterday and today in Washington, D.C., the Reagan-Udall Foundation is facilitating a public meeting of its Independent Expert Panel on food.  The independent expert panel has been charged with evaluating the structure, leadership, authorities,…
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  • Friday, September 30, 2022
    The Reagan-Udall Foundation review team gets an earful about FDA’s problems - Food Fix
    On Thursday the Reagan-Udall Foundation kicked off a two-day public meeting to solicit input on the big review of FDA’s foods program, and boy, did they get feedback. Read more
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  • Thursday, September 29, 2022
    Public Meeting of the Independent Expert Panel - FDA Human Foods Program
    Join us to observe the in-person public meeting of the Food Independent Expert Panel on September 29 & 30. We'll be gathering input from invited stakeholders including consumer, research/academia, government, and industry representatives. You can…
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  • Wednesday, September 28, 2022
    FDA Enlists Ex-FDA Leadership for Independent Review of Tobacco Center - Filter Magazine
    On September 21, a two-month independent evaluation of the Food and Drug Administration’s tobacco center commenced amid concern from tobacco control experts that calls to modernize the center were not being taken seriously. In an August 22 letter to the…
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  • Monday, September 26, 2022
    FDA Patient Listening Sessions - EIN News
    FDA’s Office of Patient Affairs hosts Patient Listening Sessions. These sessions are a resource for the medical product Centers to engage with patients and their advocates. Patient Listening Sessions are one of many ways the…
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  • Thursday, September 22, 2022
    Therapeutics and Vaccines Lab Meeting
    Eric Young of TriNetX will take us through the characterization of breakthrough infections for vaccinated individuals, including children, who received both outpatient and inpatient treatment. Sonia Hernandez-Diaz, Harvard T.H. Chan School of Public…
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  • Thursday, September 22, 2022
    Diagnostics Lab Meeting
     Professor Mara Aspinall of the Diagnostic Commons housed at Arizona State University will join us to reflect on the past, present and future of diagnostic tests. Matthew Gee of Siemens will take a look at lessons learned from using real-world…
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  • Wednesday, September 21, 2022
    Review team seeks stakeholder input on FDA and announces public meeting - Food Safety News
    The Reagan-Udall Foundation is looking to collect perspectives and experiences on the Food and Drug Administration’s human foods program through a new “Stakeholder Portal.” The Reagan-Udall Foundation’s independent expert panel has been charged with…
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  • Wednesday, September 21, 2022
    Independent Expert Panel Announced to Review FDA’s Tobacco Program
    (September 21, 2022) The Reagan-Udall Foundation today announced members of an Independent Expert Panel who will conduct the operational evaluation of the Food and Drug Administration’s tobacco program. Lauren Silvis, JD, former FDA Chief of Staff, was…
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  • Tuesday, September 20, 2022
    External Review Begins Soliciting Anonymous Input on Food Programs - POLITICO Pulse
    The Reagan-Udall Foundation, the group tasked with reviewing the FDA’s food safety and tobacco programs, opened up a public portal for anonymous feedback on the FDA’s food safety program on Monday. Read more
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  • Tuesday, September 20, 2022
    FDA Committed to Strengthening U.S. Infant Formula Supply; Review Provides Roadmap to Support Ongoing Efforts - Associated Press
    For the past several months, the U.S. Food and Drug Administration has been working around the clock with our U.S. government partners, including the U.S. Department of Health and Human Services and the U.S. Department of Agriculture, to expand consumer…
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  • Friday, September 16, 2022
    Stakeholder Input Sought in Evaluation of FDA Human Foods Program- Food Safety Magazine
    The Reagan-Udall Foundation opened a Stakeholder Portal on September 16, 2022, to collect perspectives and experiences with the U.S. Food and Drug Administration’s (FDA's) human foods program. In addition, the Foundation announced a public…
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  • Friday, September 16, 2022
    Stakeholder Input Sought in Evaluation of FDA Human Foods Program
    (September 16, 2022) The Reagan-Udall Foundation today opened a Stakeholder Portal to collect perspectives and experiences with FDA’s human foods program. In addition, the Foundation announced a public meeting of its food-focused Independent Expert Panel.
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  • Saturday, September 10, 2022
    Skin lightening products are a 'regulatory black hole,' and the FDA is warning against using them - USA Today
    The FDA has launched an initiative warning about over-the-counter skin lightening products after receiving reports of side effects. The agency's Skin Facts! Initiative, announced last week, is aimed at promoting safe use of skin care products,…
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  • Thursday, September 08, 2022
    Members of FDA review panel named - Food Safety News
    The Reagan-Udall Foundation has announced five members of an independent expert panel who will conduct an operational evaluation of the Food and Drug Administration’s human foods program. Dr. Jane Henney, former FDA Commissioner, was named as chair of…
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  • Thursday, September 01, 2022
    Experts Announced for Review of FDA Human Foods Program
    (September 1, 2022) The Reagan-Udall Foundation today announced five members of an Independent Expert Panel who will conduct the operational evaluation of the Food and Drug Administration’s human foods program. Dr. Jane Henney, former FDA Commissioner,…
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  • Thursday, September 01, 2022
    FDA Foundation Releases Reports on Substance Use Disorder, Harm Reduction
    (September 1, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) has released a series of reports, in support of the U.S. Food and Drug Administration’s (FDA) ongoing efforts to develop strategies for the prevention, treatment, and management…
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  • Thursday, September 01, 2022
    A Curious Case - The Tobacco Report
    In June, long-simmering criticism of the way the U.S. Food and Drug Administration is handling premarket tobacco product applications (PMTAs) culminated in a public uproar. “The whole regulatory process is becoming surreal now,” wrote Clive Bates, an…
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  • Tuesday, August 30, 2022
    FDA Voices: FDA's Overdose Prevention Framework Aims to Prevent Drug Overdoses and Reduce Death
    In 2021, a record number of Americans – more than 107,000 – died from drug overdoses. While the loss of human life alone is staggering, we know that the effects of the drug overdose crisis are even broader, including enormous individual and societal…
    Read More
  • Friday, August 19, 2022
    Clinton FDA chief to spearhead foods review - Food Fix
    The Reagan-Udall Foundation this week announced that Jane Henney, who served as FDA commissioner during the final years of the Clinton administration, will lead the external review of FDA’s foods program. Read more
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  • Thursday, August 18, 2022
    SCOOP: FDA Tobacco Office Faces Independent Review - POLITICO Pulse
    The CDC isn’t the only federal regulator taking a cold, hard look in the mirror: Food and Drug Administration Commissioner Robert Califf called on the Reagan-Udall Foundation to review two offices within the agency. Read more
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  • Wednesday, August 17, 2022
    Henney, Silvis Tapped as Lead Evaluators
    (August 17, 2022) The Reagan-Udall Foundation announced today that former Commissioner of Food and Drugs Jane E. Henney, MD, and former FDA Chief of Staff Lauren Silvis, JD, will lead the operational evaluation of the Food and Drug Administration’s human…
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  • Thursday, August 11, 2022
    The increasing number of novel tobacco products has prompted the agency to review its processes, procedures and leadership structure - Treatment Magazine
    Work is poised to get underway on a somewhat rare internal review by the U.S. Food and Drug Administration (FDA) that could impact how the agency processes new tobacco products and enforces the sale of them by retailers. Read more.
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  • Sunday, August 07, 2022
    It’s about to get easier to access affordable naloxone - The Washington Post
    The first shipment of naloxone in a new national effort to reverse overdoses arrived somewhat unceremoniously.
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  • Wednesday, August 03, 2022
    Big shakeups under way in much-criticized U.S. health agencies - JD Supra
    While most regular folks wouldn’t give a hill of beans about the organization of bureaucracies in Washington, D.C., frustrated taxpayers should be taking note of seismic rumblings about restructurings that are shaking some of the biggest, most powerful,…
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  • Tuesday, August 02, 2022
    Inside FDA’s big food reboot - Food Fix
    When FDA announced last month it had commissioned an outside evaluation of its foods program (as well as tobacco), it was seen by many as a formal, if somewhat tepid, admission that something had gone very wrong at the agency.
    Read More
  • Thursday, July 21, 2022
    FDA Head Orders a Review of Its Nicotine Division, to Mixed Response - Filter
    On July 20, Robert Califf, the head of the Food and Drug Administration (FDA), announced that he would commission external experts to conduct “a comprehensive evaluation” of the agency’s food and nicotine divisions. Read more
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  • Thursday, July 21, 2022
    FDA confronts ‘sub-optimal environment’ for food safety with ‘top to bottom’ review - Food Navigator
    Facing sharp criticism in the media that FDA’s approach to food safety is “broken,” “Byzantine” and a “ridiculous joke,” the agency is undertaking a “top to bottom” review of the “structure, function, funding and leadership” of its food program, agency…
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  • Thursday, July 21, 2022
    Therapeutics/Vaccines Lab Meeting
    Join us Thursday, July 21 at 3 pm ET for the July Therapeutics & Vaccines lab Meeting. We’ll be hearing from Elizabeth Eldridge of Health Catalyst. Liz will be describing the new research project they are taking on at the request of the Evidence…
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  • Thursday, July 21, 2022
    Diagnostics Lab Meeting
    Join us Thursday, July 21 at noon ET to hear from Dr. Keith Campbell of FDA's Center for Devices and Radiological Health. He'll be speaking about Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD), a public-private…
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  • Wednesday, July 20, 2022
    FDA weighs oversight changes after formula, Juul troubles - Associated Press
    The head of the Food and Drug Administration has asked for a review of the agency’s food and tobacco programs following months of criticism over their handling of the baby formula shortage and e-cigarette reviews.
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  • Wednesday, July 20, 2022
    F.D.A. Seeks Outside Review of Troubled Food and Tobacco Units - New York Times
    The Food and Drug Administration has commissioned a review of its food and tobacco programs following public outrage over baby formula  shortages and concerns about flavored nicotine products. Dr. Robert Califf, the head of the F.D.A., said the…
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  • Tuesday, July 19, 2022
    Amid controversies, FDA seeks advice on food and tobacco operations - The Washington Post
    The head of the Food and Drug Administration said Tuesday he is asking outside experts to conduct a comprehensive evaluation of the agency’s food and tobacco programs, which in recent months have endured sharp criticism involving two high-profile…
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  • Tuesday, July 19, 2022
    FDA Conducting Evaluation of Key Agency Activities to Strengthen Operations
    In February 2022, I rejoined the U.S. Food and Drug Administration as Commissioner of Food and Drugs, having served in the role five years earlier. Since my return, the agency has taken many significant actions that benefit the public health. Yet at the…
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  • Tuesday, July 19, 2022
    FDA announces external review of food safety and tobacco regulatory offices - POLITICO
    Food and Drug Administration Commissioner Robert Califf said on Tuesday that he has ordered an external review of the agency’s offices on food safety and tobacco regulation.
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  • Tuesday, July 19, 2022
    FDA leader hiring affiliated foundation to review problems at food side of agency - Food Safety News
    A shakeup of the chain of command at the FDA may be coming, but the beginning of the release of details is at least 60 working days away. FDA Commissioner Dr. Robert Califf told Food Safety News today that the agency has hired an outside…
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  • Thursday, June 16, 2022
    Therapeutics/Vaccines Lab Meeting
    Beyond the learning acceleration of our COVID-19 Evidence Accelerator lab meetings, the Evidence Accelerator model includes “engines” of evidence generation. At the June 16th Therapeutics and Vaccines meeting, we’ll review the results and…
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  • Thursday, June 16, 2022
    Diagnostics Lab Meeting
    Join the COVID-19 Diagnostics Evidence Accelerator  to check-up on what’s happening with the Mayo Clinic. Since Mayo’s (and their research partners at Yale University) participation in our research project looking at use patterns and performance of…
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  • Tuesday, June 14, 2022
    Tracking and Monitoring of Antimicrobial Use in Food-Producing Animals
    Exploring the Potential for a Public-Private Partnership to Support the Tracking and Monitoring of Antimicrobial Use in Food-Producing Animals Virtual Public Forum Tuesday, June 14, 2022 1-3pm Eastern Time
    Read More
  • Wednesday, June 01, 2022
    Alzheimer’s Evidence Accelerator Modeled On FDA COVID Project Floated By USAgainstAlzheimer’s - Pink Sheet
    Patient organization exploring development of a multi-stakeholder forum on real world evidence that, among other things, could address research questions posed by the Centers for Medicare and Medicaid Services in its national coverage determination for…
    Read More
  • Thursday, May 19, 2022
    Therapeutics/Vaccines Lab Meeting
    This month we will learn more about the opportunity to ‘listen’ for safety signals in social media from the Sanofi Digital team, as they share some of their advanced analytics and visualization regarding what is being said about COVID vaccine safety,…
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  • Thursday, May 19, 2022
    Diagnostics Lab Meeting
    In this month's Diagnostics Lab meeting, we will be hearing from two groups working to enable the flow of health information throughout numerous vendors, implementers, networks and governance frameworks. We’ll hear first from Mariann Yeager, CEO of The…
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  • Tuesday, May 17, 2022
    2022 Annual Public Meeting
    More than 200 patient, consumer, industry, research, and government stakeholders joined the Foundation’s Annual Public Meeting of our Board of Directors on May 16, 2022. The event featured candid discussions with senior FDA leadership on topics ranging…
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  • Tuesday, May 17, 2022
    Woodcock Weighs in on ARPA-H - POLITICO's Prescription Pulse
    If the proposed Advanced Research Projects Agency for Health is created, new treatment candidates would need to engage with FDA early on to help determine appropriate clinical testing design, FDA principal deputy commissioner Janet Woodcock said Monday…
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  • Monday, May 16, 2022
    2022 Annual Public Meeting
    2022 Annual Public Meeting May 16, 2022 2:30-4 PM Eastern Each year, the Reagan-Udall Foundation for the FDA conducts an Annual Public Meeting of its Board of Directors to share its activities in support of the U.S. Food and Drug Administration. …
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  • Tuesday, May 03, 2022
    Global Genes and the Orphan Disease Center of the University of Pennsylvania Host 7th Annual RARE Drug Development Symposium - Yahoo Finance
    -Global Genes, a leading rare disease patient advocacy organization, today announced its 7th annual 
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  • Thursday, April 21, 2022
    Evidence Accelerator: Therapeutics/Vaccines Lab Meeting
    The topic for this month's Therapeutics/Vaccines Lab Meeting is "Test to Treat." This is our once-monthly COVID-19 Evidence Accelerator Therapeutics/Vaccines Lab Meeting. This meeting is held the third Thursday of every month at 3pm ET. If you are…
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  • Thursday, April 21, 2022
    Evidence Accelerator: Diagnostics Lab Meeting
    This month's Diagnostics Lab meeting we will look at LAMP-based diagnostics; Testing in the airline industry and air travel. We will hear presentations from Dr. Nilay Shah of Delta Airlines and Randy True of FloodLamp Biotechnologies. This is the once-…
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  • Thursday, March 31, 2022
    FDA says IT modernization came at right time for COVID - Regulatory Focus
    While the US Food and Drug Administration (FDA) began the process of modernizing its IT systems before the COVID-19 pandemic, the crisis accelerated much of that work and allowed the agency to streamline much of its activities at a critical moment in…
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  • Wednesday, March 30, 2022
    FDA’s Technology and Data Modernization in Action in 2022
    In partnership with the Reagan-Udall Foundation, the FDA and the Friends of Cancer Research launched the Evidence Accelerator (EA) to advance the use of Real-World Data (RWD) to inform the COVID-19 response. In collaboration, ODT and the FDA’s Office of…
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  • Wednesday, March 30, 2022
    Make Naloxone More Accessible to At-Risk Americans, Experts Say - MedPage Today
    Strategies to expand access to naloxone (Narcan) for the prevention of opioid overdoses were explored during a webinar hosted by the Reagan-Udall Foundation for the FDA on Tuesday. Over 100,000 people died from drug overdoses over a 12-month…
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  • Tuesday, March 29, 2022
    Naloxone Access: Answering Questions
    Naloxone Access: Answering Questions Virtual Public Meeting  Tuesday, March 29, 2022 12:30 – 3 PM Eastern Time
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  • Friday, March 18, 2022
    FDA to Convene Workshop on Naloxone Access - POLITICO's Prescription Pulse
    FDA and the Reagan-Udall Foundation will hold a virtual meeting on March 29 to discuss strategies to increase access to naloxone, the opioid overdose reversal drug. Read the full story here.
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  • Thursday, March 17, 2022
    Naloxone Access: Answering Questions
    What: The Reagan-Udall Foundation for the FDA (FDA Foundation), in collaboration with the U.S. Food and Drug Administration, is hosting a virtual public meeting to explore questions about access to naloxone, a drug used to reverse opioid overdoses. Harm…
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  • Thursday, March 17, 2022
    FDA, Reagan-Udall Foundation for the FDA to Hold Important Public Workshop to Discuss Naloxone Access
    The U.S. Food and Drug Administration will host a virtual public workshop on Mar. 29, to discuss critical questions around access to naloxone, a drug used to reverse opioid overdoses. The workshop is a collaboration with the Reagan-Udall…
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  • Thursday, March 17, 2022
    Evidence Accelerator: Therapeutics/Vaccines Lab Meeting
    During this week's Therapeutics/Vaccines Lab meeting we will host an interview moderated by Duke University's Dr. Murali Doraiswamy. During the interview, Dr. Doraiswamy will speak with Dr. Patrizia Cavazzoni of FDA's Center for Drug Evaluation and…
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  • Thursday, March 17, 2022
    Evidence Accelerator: Diagnostics Lab Meeting
    This week's Diagnostics Lab Meeting will feature presentations focused on tying diagnostics and therapeutics, using patient-level variant testing to determine availability of certain monoclonal antibodies (mAbs).
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  • Wednesday, March 16, 2022
    US FDA Tries To Shape The Accelerated Approval Reform Narrative - Pink Sheet
    US Food and Drug Administration officials appear to want stakeholders, and maybe more importantly, lawmakers, to let go of the notion that failure is not an option with accelerated approval. “There is going to be uncertainty regarding whether the drug…
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  • Friday, March 11, 2022
    Accelerated Approval Program Virtual Public Meeting
    The Accelerated Approval Pathway was created by Congress to allow patients with a serious or life-threatening disease earlier access to a potentially important treatment. At this virtual public meeting we explored the insights and lessons learned in…
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  • Thursday, March 10, 2022
    Meharry’s Dr. Hildreth Joins FDA Foundation Board- The Tennessee Tribune
    The Reagan-Udall Foundation for the Food and Drug Administration (FDA Foundation) has appointed four new Board members: David C. Fajgenbaum, MD, MBA, MSc, FCPP, University of Pennsylvania; William N. Hait, MD, PhD, Johnson & Johnson; James E.K.…
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  • Tuesday, March 08, 2022
    Chelsea Project Tapped for $893,500 Rapid-Testing Research Grant - The Digital Journal
    Two organizations with roots at MIT have joined forces to improve our understanding and use of rapid antigen tests in real-world settings. IDx20, headed by MIT scientist Irene Bosch, together with the Chelsea Project are the recipients of…
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  • Monday, March 07, 2022
    Reagan-Udall Foundation for the FDA Announces New Board Members
    (March 7, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) has appointed four new members to our Board of Directors: 
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  • Tuesday, March 01, 2022
    A major boost for NIH and FDA’s private-sector partnerships - STAT News
    Congress is dramatically increasing the amount of money that the NIH and FDA spend on research partnerships with the private sector — namely, collaborations with drug and device companies.
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  • Tuesday, March 01, 2022
    Reagan-Udall Foundation for the FDA Awards $1.8 Million in Research Funding for Studies on the Real-World Performance of COVID-19 Tests
    (March 1, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) awarded $1.8 million in funding for two research projects evaluating the Real-World Performance of In Vitro Diagnostics (PIVD). Beth Israel Deaconess Medical Center will receive $…
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  • Thursday, February 17, 2022
    COVID-19 Evidence Accelerator: Therapeutics/Vaccines Lab Meeting
     02/17/2022 - 03:00 PM During our February Therapeutics/Vaccines Lab Meeting we will hear from colleagues at WHO and Gavi, TriNetX, and Kaiser Permanente California discuss ongoing vaccine research. Nevine Zariffa will also join us to discuss what…
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  • Thursday, February 17, 2022
    COVID-19 Evidence Accelerator: Diagnostics Lab Meeting
    This is the once-monthly COVID-19 Evidence Accelerator Diagnostics Lab Meeting. These meetings occur the third Thursday of every month at 12 pm ET.  If you are interested in attending the meeting series please email us at evidenceaccelerator@…
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  • Friday, February 11, 2022
    Real-World Data Webinar Series: Considerations for the Use of RWD and RWE
    Real-World Data Webinar Series: Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products (Guidance for Industry) Friday, February 11, 2022 11 AM-12 PM Eastern  
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  • Friday, February 04, 2022
    This Week at FDA
    The Reagan-Udall Foundation for the FDA published a report today that looks into the lessons learned about the clinical evaluation of therapeutics for COVID-19. The 21-page report is based on discussions from a workshop last September. …
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  • Friday, February 04, 2022
    Reagan-Udall Foundation for the FDA Issues Paper on COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics
    (February 4, 2022) The Reagan-Udall Foundation for the FDA, at the request of the U.S. Food and Drug Administration, has released a report that outlines initial lessons learned from the federal government’s and research communities’ COVID-19 response and…
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  • Friday, January 28, 2022
    Real-World Data Webinar Series: Registries
    Real-World Data Webinar Series: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products (Guidance for Industry) Friday, January 28, 2022 1-2 PM Eastern
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  • Tuesday, December 14, 2021
    2021 Innovations in Regulatory Science Awards
    The fifth annual Innovations in Regulatory Science Awards presented by the Reagan-Udall Foundation for the FDA will be held Tuesday, December 14, 2021
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  • Monday, December 13, 2021
    FDA Advances Reorganization Proposal for Unified Human Foods Program, Field Operations and Additional Modernization Efforts - Associated Press Online
    Today, the U.S. Food and Drug Administration is providing an update on its efforts to create a unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model, including additional details about the proposed structure, status of…
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  • Tuesday, December 07, 2021
    2021 Innovations in Regulatory Science Awards Highlights
    Celebrating Excellence in Regulatory Science More than 200 regulatory science colleagues joined our fifth annual Innovations in Regulatory Science Awards, celebrating outstanding leadership, innovation, and advocacy that safeguards this nation's…
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  • Friday, December 03, 2021
    Real-World Data Webinar Series: Data Standards
      Real-World Data Webinar Series: Data Standards for Drug and Biological Product Submissions Containing Real-World Data – Draft Guidance for Industry Friday, December 3, 2021
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  • Thursday, November 04, 2021
    A Public Webinar Series on FDA-Issued Guidance on Real-World Evidence
    A Public Webinar Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry   November 4, 2021 1:30-2:30 pm ET
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  • Monday, October 18, 2021
    A Practical Research Agenda for Treatment Development for Stimulant Use Disorder
    A virtual public workshop to discuss a practical research agenda toward treatment development for stimulant use disorder. 
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  • Tuesday, October 05, 2021
    Industry Voices—COVID-19 vaccine rollout shows real-world evidence was ready for the spotlight - Fierce Healthcare
    Just 10 months since administration of the first COVID-19 vaccine dose, hundreds of millions of people worldwide have been inoculated. As of mid-August, more than 4 billion vaccine doses have been administered worldwide, and over 50% …
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  • Tuesday, September 28, 2021
    FDA's Dr. Peter Marks, The COVID-19 Research Database, and Rep. Patrick Kennedy Recognized with Innovations in Regulatory Science Awards
    WASHINGTON, Sept. 28, 2021 /PRNewswire/ -- The Reagan-Udall Foundation for the FDA will present 2021 Innovations in Regulatory Science Awards to Peter Marks, MD, PhD, The COVID-19 Research Database, and former U.S. Representative…
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  • Tuesday, September 28, 2021
    COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics
    COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics  
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  • Monday, September 27, 2021
    FDA’s Dr. Peter Marks, The COVID-19 Research Database, and Rep. Patrick Kennedy Recognized with Innovations in Regulatory Science Awards
    (September 27, 2021) The Reagan-Udall Foundation for the FDA will present 2021 Innovations in Regulatory Science Awards to Peter Marks, MD, PhD, The COVID-19 Research Database, and former U.S. Representative Patrick J. Kennedy.  
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  • Tuesday, September 14, 2021
    Clinical trials capacity should be considered strategic asset - BioCentury
    The U.S. government should consider creating a strategic national stockpile of capacity for clinical research. Government could also fund and help create a standing network of clinical trial sites that can immediately respond to future pandemics — and…
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  • Wednesday, September 08, 2021
    Virtual Public Workshop on COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics - Trial Site
    Sponsored by Reagan-Udall Foundation, key federal leadership and important stakeholders join a virtual public workshop on September 28 titled  “Federal COVID-19 Response: Clinical Evaluation of Therapeutics Lessons Learned.”  The event will…
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  • Tuesday, June 29, 2021
    Helping Patients Access Investigational Treatments - Cancer Commons
    Published on Cancer Commons, June 29, 2021, Curious Dr. George asks two leaders from the Reagan-Udall Foundation for the Food and Drug Administration (FDA) how their organization supports the FDA by striving to facilitate patient access to…
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  • Wednesday, June 23, 2021
    RDBA and FDA Foundation Partner to Provide Turnkey Resources to Retail Dietitians
    (July 23, 2021) Today, the Reagan-Udall Foundation for the FDA (FDA Foundation) and the Retail Dietitians Business Alliance (RDBA) jointly launched Supporting Healthier Eating in the New Normal: The Ultimate Retail Dietitians Toolkit. The toolkit…
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  • Tuesday, June 15, 2021
    Real-World Evidence Accelerator Facing Data Access Challenges For Vaccines - Scrip News for Pink Sheet
    The Reagan-Udall Foundation’s Evidence Accelerator program is navigating novel data flow challenges when it comes to assessing the safety and effectiveness of COVID-19 vaccines. The Evidence Accelerator was launched in April 2020 by Reagan-Udall, a…
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  • Thursday, June 03, 2021
    Reagan-Udall Foundation for the FDA Announces Two New Board Members
    (June 3, 2021) The Reagan-Udall Foundation for the Food and Drug Administration (FDA Foundation) is expanding its leadership with the addition of two new Board members: Christie Boutte, PharmD, RPh, Senior Vice President of Reimbursement, Innovation, and…
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  • Wednesday, June 02, 2021
    What Drives COVID Vaccine Hesitancy Among Moms? - MedPage Today
    Mothers are particularly hesitant about getting the COVID-19 vaccine for themselves and their children, according to the latest data.
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  • Wednesday, May 19, 2021
    US FDA Eyes New Investigational Drug Label Requirements That Bring International Harmonization - Pink Sheet
    The US Food and Drug Administration is considering new regulatory action to create more consistency in the labeling of investigational drugs to help reduce medication errors and protect patients as well as the integrity of the clinical trial results.…
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  • Tuesday, May 18, 2021 - Wednesday, May 19, 2021
    Potential Medication Error Risks With Investigational Drug Container Labels
    FDA and the Reagan-Udall Foundation for the FDA held a virtual public meeting on the potential medication error risks with investigational drug container labels. We solicited input from stakeholders (e.g., sponsors, investigators, clinical sites,…
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  • Friday, May 14, 2021
    FDA documents shed light on chaotic COVID decision-making during Trump administration - BioCentury
    Internal FDA and White House communications released by FDA in response to a Freedom of Information Act request provide a glimpse into the in-fighting, leaking and chaotic decision-making during some of the most fraught moments of the pandemic during the…
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  • Friday, May 14, 2021
    OSE's annual report details Sentinel efforts during COVID pandemic - Regulatory Focus
    The US Food and Drug Organization’s (FDA’s) Office of Surveillance and Epidemiology issued its first-ever annual report summing up the office’s work.   The scope of the office’s charge meant that during the pandemic, staff effort was largely…
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  • Wednesday, May 12, 2021
    2021 Annual Public Meeting
    On May 12, 2021, more than 100 stakeholders joined Reagan-Udall Foundation for the FDA Board of Directors for their Annual Public Meeting. The discussion centered on how public-private partnerships help advance the mission of FDA. Board members…
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  • Wednesday, May 12, 2021
    2021 Annual Public Meeting
    Each year, the Reagan-Udall Foundation for the FDA conducts an Annual Public Meeting of its Board of Directors to share its activities in support of the U.S. Food and Drug Administration. This free virtual meeting is open to the public, but advanced…
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  • Friday, April 16, 2021
    Listening to patients: The FDA goes from strength to strength - The Pharma Letter
    Hosted by the FDA’s Office of Patient Affairs (OPA), together with the National Organization for Rare Disorders (NORD) and the Reagan-Udall Foundation, Patient Listening Sessions are small and informal conversations that bring patients/caregivers and…
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  • Tuesday, March 23, 2021
    How to Talk to Patients Reluctant to Get a COVID-19 Vaccine - Medscape
    Family physician Mitchell A. Kaminski, MD, MBA, was still awash in feelings of joy and relief at recently being vaccinated against COVID-19 when a patient's comments stopped him cold. The patient, a middle-aged man with several comorbidities, had just…
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  • Tuesday, March 23, 2021
    'Part of recovery is awareness': Pandemic casts harsh spotlight on industry-wide lack of diversity in clinical trials -Endpoints
    Moderna emerged as an early leader in the race for a vaccine to stop Covid-19 in its tracks. The Cambridge, Massachusetts-based biotech bounded through development of one of the world’s first mRNA vaccines, but in September — when the pandemic was…
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  • Wednesday, March 17, 2021
    COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients
    The COVID-19 pandemic remains a significant global threat. However, despite urgent need, there remains uncertainty surrounding best practices for pharmaceutical interventions to treat COVID-19. In particular, conflicting evidence has emerged surrounding…
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  • Tuesday, March 16, 2021
    APhA Foundation names 2021 Jacob W. Miller Award recipient - Drug Store News
    Susan Winckler, CEO of the Reagan-Udall Foundation for the Food and Drug Administration, is the American Pharmacists Association Foundation’s 2021 recipient of the Jacob W. Miller Award. The award recognizes individuals who help to advance the Foundation…
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  • Tuesday, March 02, 2021
    Industry Voices—Harnessing a watershed moment for real-world data - Fierce Healthcare
    Across every facet of life, 2020 tested our resolve and resilience. COVID-19 stretched our systems to the breaking point, exposing inexcusable gaps and limitations in our systems. As a force of creative destruction and reinvention, however, it also…
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  • Monday, March 01, 2021
    Shot in the Arm: COVID-19 Boost to RWD - PharmaVOICE
    It’s early 2021 in the Northeast and a major snowstorm has just been announced. Schools will be closed for the next two days. Kids will be home and likely, quite happy to be off from school. Under normal circumstances, parents would be home too, trying…
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  • Monday, March 01, 2021
    COVID-19 Diagnostics Market Size Worth USD 8.04 Billion at 2.7% CAGR; Pharmaceutical Giants Such as Abbott and Roche to Pump More Funds for R&D Activities: Fortune Business Insights™ - Digital Journal
    The global COVID-19 diagnostics market size is projected to reach USD 8.04 billion by 2027, exhibiting a CAGR of 2.7% during the forecast period.
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  • Wednesday, January 20, 2021
    FDA Foundation Announces Research Funding Opportunity
    The Reagan-Udall Foundation for the FDA is pleased to announce the availability of funds to support studies of the real-world performance of two types of COVID-19 diagnostic tests. The purpose of this research is to evaluate real-world performance…
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  • Sunday, January 03, 2021
    COVID-19 Vaccine Confidence Project - Journal of the American Pharmacists Association
    Published in the Journal of the American Pharmacists Association, June 11, 2021, Throughout much of 2020 and the beginning of 2021, while coronavirus disease 2019 (COVID-19) continued to grow and spread, government and public health officials worldwide
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  • Tuesday, December 08, 2020
    2020 Innovations in Regulatory Science Awards Dinner
    Download the full event program
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  • Tuesday, October 13, 2020
    2020 Annual Public Meeting Highlights
     
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  • Saturday, April 11, 2020 - Saturday, April 11, 2020
    Real-World Evidence On COVID-19: US FDA Approaching With 'Sense Of Urgency'
    The COVID-19 pandemic is forcing the US Food and Drug Administration to step outside its comfort zone when it comes to using real-world evidence to inform rapid regulatory decision-making and clinical trial design. This experience could have a…
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  • Wednesday, December 11, 2019
    2019 Innovations in Regulatory Science Awards Dinner
    Join leaders in the regulatory field on December 11, 2019, to honor leaders and innovators making a significant impact on America's public health. 6 p.m. - 9 p.m. The Mayflower Hotel  1127 Connecticut Avenue NW Washington, DC 20036 Meet our 2019…
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  • Thursday, December 05, 2019 - Friday, December 06, 2019
    Repurposing Off-Patent Drugs: Research & Regulatory Challenges
    Join us for an interactive two-day workshop to discuss challenges around repurposing drugs that are already on the market but lack commercial and regulatory incentives for further research and development.
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  • Monday, June 24, 2019
    Visit us at DIA Global
    DIA 2019 Global Annual Meeting in San Diego
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  • Thursday, May 16, 2019
    Project Facilitate: Enhancing the Single Patient IND Process for Oncology
    May 16, 2019   |   1:00 PM to 3:30 PM FDA White Oak Campus Building 31, Room 1503 - Great Room 10903 New Hampshire Avenue, Silver Spring, MD 20993  
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  • Thursday, May 02, 2019
    2019 Annual Public Meeting Highlights
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  • Thursday, May 02, 2019
    2019 Annual Public Meeting
    Annual Public Meeting Set for May 2, 2019 Each year, the Foundation conducts an annual public meeting to discuss its activities and support of the U.S. Food and Drug Administration. The 2019 Annual Public Meeting will focus on pressing FDA initiatives…
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  • Monday, March 18, 2019
    Collecting Data from EA Treatment for Regulatory Submissions Presentation
    Executive Director June Wasser will present Collecting Data from EA Treatment for Regulatory Submissions at the Life Science Compassionate Access Summit at 4:00 pm, Monday, March 18th in Philadelphia. She will focus on: 
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  • Tuesday, December 04, 2018
    2018 Innovations in Regulatory Science Awards Dinner Highlights
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  • Tuesday, December 04, 2018
    2018 Innovations in Regulatory Science Awards Dinner
    The Reagan-Udall Foundation for the FDA honored two longtime U.S. Food and Drug Administration leaders and an independent public-private partnership as the 2018 recipients of the Innovations in Regulatory Science Awards. This year’s Innovations in…
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  • Monday, November 19, 2018
    Leveraging Real-World Treatment Experience from EA Protocols
    See Event Highlights and Download the Meeting Report  Monday, November 19, 2018   |  10:00 AM to 4:30 PM U.S. Food and Drug Administration White Oak Campus, Building 31, Great Room 10903 New Hampshire Avenue, Silver Spring, MD…
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  • Monday, November 19, 2018
    Expanded Access Programs and Real-World Evidence: Public Meeting
    Expanded access programs, sometimes also called “compassionate use” programs, provide patients with serious or immediately life-threatening diseases or conditions access to investigational products outside of clinical trials
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  • Friday, May 04, 2018
    2018 Annual Public Meeting Highlights
    Collaboration and partnership, two key aspects of the Reagan-Udall Foundation for the FDA’s commitment to advancing regulatory science, were on full display when leaders from the FDA, the regulatory science community and the medical community gathered in…
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  • Tuesday, December 05, 2017
    2017 Innovations in Regulatory Science Awards
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  • Thursday, January 31, 1924
    FDA Hosts Public Psychedelics Discussion, Discloses Major Growth On Number Of New Psychiatric Drugs Filings Post-2000 - Benzinga
    The U.S. Food and Drug Administration (FDA) together with the Reagan-Udall Foundation for the FDA are hosting a virtual public meeting on psychedelic research, Jan. 31 to Feb. 1. Titled "Advancing Psychedelic Clinical Study…
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  • Thursday, September 20, 1923
    FDA proposes framework for collecting antimicrobial use data - Journal of the American Veterinary Medical Assn
    The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) is seeking public comment on a report outlining a potential framework for establishing a public-private partnership (PPP) to collect and analyze antimicrobial use (…
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  • Tuesday, April 04, 1922
    Call for Nominations: Reagan-Udall Foundation for the FDA Seeks Nominations for the Innovations in Regulatory Science Awards
    (April 4, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) seeks nominations for its annual Innovations in Regulatory Science Awards. These awards recognize outstanding contributions made by individuals or organizations in the field of…
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  • The Floridian: Congress Should Press for FDA Reform to Crack Down on Illegal E-Cigarettes
    According to findings by the Reagan Udall Foundation, that is exactly what is happening as stakeholders navigating the process “expressed concerns about a lack of clarity, transparency, and communication” regarding the CTP’s priorities and decision-…
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  • 2024 Innovations in Regulatory Science Awards
    Join the Reagan-Udall Foundation for the FDA as we bring the regulatory science community together to recognize the leadership, scientific breakthroughs, and unwavering advocacy that helps safeguard America’s public health. …
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  • 2023 Innovations in Regulatory Science Awards
    Join the Reagan-Udall Foundation for the FDA as we bring the regulatory science community together to recognize the leadership, scientific breakthroughs, and unwavering advocacy that helps safeguard America’s public health. …
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  • RDBA and FDA Foundation Partner to Provide Turnkey Resources to Retail Dietitians - The Associated Press
    Today, the Reagan-Udall Foundation for the FDA (FDA Foundation) and the Retail Dietitians Business Alliance (RDBA) jointly launched Supporting Healthier Eating in the New Normal: The Ultimate Retail Dietitians Toolkit.
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  • Post-COVID-19 Syndrome: Leveraging the Patient Perspective and Technological Innovations to Enable the Delineation of Effective Treatments - The Journal Drugs
    More than 32 million individuals have survived a confirmed COVID-19 viral infection in the USA [1, 2], and a substantial proportion of post-COVID survivors are suffering from prolonged, recurrent, and/or newly emerging symptoms that span across…
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  • FDA’s Vaccine Efforts Expand to Developing Public Confidence - American Medical Association
    Scientists at the Food and Drug Administration (FDA) have devoted countless hours to ensuring that the COVID-19 vaccines being deployed and those in the development pipeline are safe and effective. But it’s another task being done outside of the lab that…
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  • Industry Voices — COVID-19 vaccine development was a historic achievement. We'll need cutting-edge technology to make sure it ends the pandemic - Fierce Healthcare
    After nine months of suffering, isolation and economic downturn on an unprecedented international scale, the expedited development and approval of COVID-19 vaccines has shown us the light at the tunnel’s end. Having an end in sight is not the same as…
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  • What if we captured the spirit and urgency of Covid-19 research to cure cancer?
    In recent months, scientists and policymakers around the globe have rallied together with one common goal: to eliminate Covid-19. Budgets have been revised to funnel money toward research, competitive barriers between scientists and companies have been…
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  • Vaccine hesitancy part 2: Effective strategies for a human-centered health campaign - Atlantic Council
    Trust is health’s most valuable player COVID-19 has made clear that the politicization of health is incredibly dangerous; the health of billions of individuals is at stake, but so too is trust in pharmaceutical companies, in the scientific process…
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  • Leading Health Care and Infectious Disease Experts Join Together to Discuss COVID-19 Vaccine Safety, Equity and Distribution - Associated Press
    December 17, 2020 (Washington, D.C.) As Americans patiently await their turn for COVID-19 vaccination, a group of leading medical, health equity and public policy experts discussed and answered questions as part of a national briefing today about…
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  • US Agency Grants Approval of Pfizer's COVID Vaccine And Doses Are Expected in Days - Science Alert
    US regulators have authorised the first coronavirus vaccine for emergency use, marking an inflection point in the pandemic and kicking off what's set to be the largest vaccination campaign in US history.
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  • Countdown to a Coronavirus Vaccine - The New Yorker
    On a hot afternoon in August, Debbie Honeycutt walked into the crowded waiting room of the Medical Center for Clinical Research, an experimental-treatment facility tucked inside a squat office building in San Diego. She was volunteer number four hundred…
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  • Michael J. Fox Foundation for Parkinson's Research Honored with Advocacy/Policy Award from Reagan-Udall Foundation for the FDA - PR Newswire
    NEW YORK, Dec. 9, 2020 /PRNewswire/ -- The Michael J. Fox Foundation for Parkinson's Research (MJFF) has received the Advocacy/Policy Award from the Reagan-Udall Foundation for the Food and Drug Administration. MJFF is the second…
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  • Surescripts Fireside Chat with Dr. Amy Abernethy, Principal Deputy Commissioner and Acting CIO, FDA
    Tom Skelton, CEO of Surescripts, recently spoke with Dr. Amy Abernethy of the FDA, about the impact of COVID-19 and the evolving data needs of public health.    
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  • FDA’s Amy Abernethy, Friends of Cancer Research, and The Michael J. Fox Foundation for Parkinson’s Research Honored with Innovations in Regulatory Science Awards
    Honorees to be recognized virtually on December 8, 2020
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  • We may soon have a COVID-19 vaccine. But will enough people take it? - Reuters
    ZURICH/LONDON (Reuters) - With COVID-19 vaccine trial results looking positive, governments and pharmaceutical firms face their next daunting challenge: convincing the world to get inoculated. Public resistance to vaccines has been much discussed this…
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  • In Brief - The Cancer Letter
    Reagan-Udall receives $250,000 from Rockefeller Foundation for COVID-19 Diagnostics Evidence Accelerator
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  • Officials clarify military role in coronavirus vaccination amid wariness - Roll Call
    President Donald Trump has often touted the role of the military in distributing a COVID-19 vaccine, but health officials close to the process who are concerned about public distrust are taking pains to say the federal government won’t actually be…
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  • Black Americans are the most hesitant to get a COVID-19 vaccine - USA Today
    Black Americans distrust the government so much they're not participating in large numbers in COVID-19 clinical trials, and many say they won't get a COVID-19 vaccine – at least not until many others get it. Although the first two large clinical…
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  • Reagan-Udall Foundation for the FDA Secures New Grant from The Rockefeller Foundation for COVID-19 Diagnostics Evidence Accelerator
    The Reagan-Udall Foundation for the FDA has received funding from The Rockefeller Foundation to support the COVID-19 Diagnostics Evidence Accelerator launched earlier this year in collaboration with Friends of Cancer Research. As a science-driven…
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  • Rushing COVID-19 Vaccination Could Undermine Overall Success, Vaccine Experts Warn FDA - IDSE
    Extraordinary and unusual measures may be needed to rapidly develop and distribute a vaccine against SARS-CoV-2, but those efforts should not compromise the safety and efficacy of any product that reaches the market, according to the FDA Vaccines and…
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  • ‘There’s only one chance to do this right’—FDA panel wrestles with COVID-19 vaccine issues - Science
    Concerns raised yesterday by an advisory group to the U.S. Food and Drug Administration (FDA) may once again tap the brakes on Operation Warp Speed, the U.S. government’s $10.8 billion push to rapidly move candidate COVID-19 vaccines from concept to…
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  • Patient Warehousing Emerges As Another COVID-19 Vaccine Confidence Problem - Pink Sheet
    Executive Summary CDC officials designing distribution plans worry some eligible for vaccination may wait for a better product to emerge. Federal officials are now confronting another challenge for the uptake of a potential coronavirus vaccine –…
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  • FDA advisory committee debates safety and efficacy standards for a coronavirus vaccine - The Washington Post
    Vaccine experts on Thursday rigorously debated the Food and Drug Administration’s planned standards for clearing a coronavirus vaccine quickly for broad use, discussing what level of evidence would be sufficient to establish safety and…
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  • Researchers Find Doubts About COVID-19 Vaccine Among People Of Color - NPR
    The Food and Drug Administration is preparing for the eventual rollout of one or more COVID-19 vaccines — by identifying the concerns that some people have about taking such a vaccine. At a meeting Thursday of experts advising the FDA on COVID-19…
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  • Facing vaccine doubts, US grapples with building confidence in coronavirus shots - BioPharma Dive
    Dive Brief: The Centers for Disease Control and Prevention does not back mandates that healthcare workers or other essential employees receive COVID-19 vaccines, with a CDC official stating Thursday the agency would prefer instead to "build trust and…
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  • US faces major hurdles for COVID-19 vaccine distribution: Vaccine advisory committee - MSN
    Any coronavirus vaccine that could be authorized for emergency use by the U.S. Food and Drug Administration (FDA) faces several additional hurdles after completing the final stage of clinical trials. That was the theme of key issues addressed today by…
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  • FDA Panel Stresses Safety, Diversity, Efficacy for COVID-19 Vax - MedPage Today
    COVID-19 vaccine safety, dueling efficacy standards, and representation of groups from racial and ethnic minorities to children drew focus Thursday at arguably the most watched FDA advisory committee meeting ever.
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  • CDC distribution roadmap, safety oversight plans, and other takeaways from FDA’s big COVID-19 vaccine meeting - ExBulletin
    In less than a year, scientists around the world have rallied against COVID-19 and developed promising vaccines that could stem the pandemic. Concerns remain, however, and, against this backdrop, senior government experts took over Thursday to discuss…
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  • Group Of Independent Experts To Advise FDA On Coronavirus Vaccine Approval - WUWM Milwaukee
    It's up to the Food and Drug Administration to decide whether a COVID-19 vaccine is safe and effective enough for public distribution. Today, the agency convened a group of independent experts to offer advice on the way forward. NPR science correspondent…
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  • In historic Covid-19 adcomm, vaccine experts debate a sea of questions — but offer no clear answers - Endpoints News
    The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers. Read more
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  • Confidence still lacking in future COVID-19 vaccines - BioWorld
    With the lack of public trust and confidence the biggest barrier to SARS-CoV-2 vaccines in the U.S., the risk of granting an emergency use authorization (EUA) to a vaccine with safety issues or questionable efficacy could destroy confidence in future FDA…
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  • Core Concept: The pandemic is prompting widespread use—and misuse—of real-world data - PNAS
    COVID-19 has swept across the world, overwhelming healthcare systems and raising countless questions about how best to diagnose patients, treat infections, save lives, and contain the pandemic. In short order, researchers have launched randomized trials…
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  • FDA study finds fear and distrust among front-line workers and minority groups around COVID-19 vaccines - Fierce Pharma
    Powerful, illuminating and sobering—that’s the description from a research group summing up its initial listening sessions with front-line workers and minority groups about a vaccine. Tasked with tapping key audiences to learn their questions and…
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  • What to expect from the official COVID-19 vaccine committee - ABC News
    As the race for an effective COVID-19 vaccine continues, the public will get inside look at one a crucial part of the Food and Drug Administration's decision-making process: the first meeting of its normally obscure advisory committee. Never…
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  • October, no surprise: COVID-19 vax AdComm booked for the 22nd - RAPS
    The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee plans to meet on 22 October to discuss matters related to authorization and licensure of vaccines for COVID-19. No application will be on the docket at…
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  • FDA Applauds Role of Clinical Trials in Fighting COVID-19 - The Association of Clinical Research Professionals
    “Clinical trials are critical” in the battle against the global COVID-19 pandemic, Amy Abernathy, principal deputy commissioner and acting CIO of the U.S. Food and Drug Administration (FDA), told attendees of the Veeva R&D and Quality Summit on…
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  • Remarks by Dr. Hahn to the Global Coalition for Regulatory Science Research
    I’m delighted to be with you today for this important meeting of the Global Coalition for Regulatory Science Research.  I only wish that we could be together in person. I want to thank Bill Slikker and his co-chair of the Scientific Program…
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  • Expanded access eRequest app allows physicians to submit EA requests online - The Cancer Letter
    The Reagan-Udall Foundation for the FDA, with input from experts at FDA, has introduced an Expanded Access eRequest app to streamline expanded access for individual patients in non-emergency settings. “Time is critical when patients have a serious or…
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  • Ask the Accelerators: Dr. William Morice of Mayo Clinic Laboratories on RWE and COVID-19 diagnostics - Aetion
    Ask the Accelerators is a series highlighting the perspectives and work of organizations and individuals participating in the COVID-19 Evidence Accelerator. Organized by the Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) and…
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  • It Just Got Easier for Physicians to Help Their Patients Gain Access to Investigational Treatments
    When a patient is in need of an important medicine, paperwork and forms are the last thing their physician wants to deal with. In some cases, it’s necessary, but the U.S. Food and Drug Administration is doing everything we can to keep it to a minimum.…
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  • New Expanded Access eRequest App Allows Physicians to Submit EA Requests Online
    Submitting expanded access requests to FDA just got easier for physicians. The Reagan-Udall Foundation for the FDA, with input from experts at FDA, today launched Expanded Access eRequest to streamline expanded access for individual patients in non-…
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  • Covid-19 Molecular Diagnostic Testing — Lessons Learned - The New England Journal of Medicine
    On February 4, 2020, the U.S. secretary of health and human services declared that emergency use of diagnostics for SARS-CoV-2 was justified, triggering emergency authority for the Food and Drug Administration (FDA) to grant an emergency use…
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  • Ask the Accelerators: Dr. Nirosha Lederer on COVID-19’s implications for the future of RWE, and what we’ve learned so far - Aetion
    Ask the Accelerators is a series highlighting the perspectives and work of organizations and individuals participating in the COVID-19 Evidence Accelerator. Organized by the Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) and…
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  • UPDATED: Aetion pushes Series B to $82M as pandemic puts real-world evidence under the spotlight - Endpoints News
    Former FDA chief Scott Gottlieb’s favorite real-world evidence platform is getting a new stream of cash, as it nears what will likely be the biggest test of the young company so far. Aetion, the New York health tech startup, has for the second time…
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  • FDA In Brief: Findings from Real-World Data Study Reveal Higher Risk of Hospitalization and Death Among Cancer Patients with COVID-19, Underscore Health Disparities
    The following quote is attributed to Harpreet Singh, M.D., Associate Director, Cancer in Older Adults and Special Populations, FDA’s Oncology Center of Excellence; and Director, Division of Oncology 2, FDA’s Center for Drug Evaluation and Research:
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  • FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability
    The U. S. Food and Drug Administration has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed development and to quickly authorize tests that the science…
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  • Industry Voices—How real-world EHR data are enhancing our understanding of COVID-19 - Fierce Healthcare
    Traditionally, the healthcare industry has moved slowly when embracing new technology innovations. However, over the past few months, it has been forced to rapidly advance to confront the challenges posed by COVID-19. One area that has received…
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  • FDA to Participate in Covid-19 Diagnostics Evidence Accelerator - Bloomberg Law
    The FDA will participate in the Covid-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research. Read more
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  • HAHN PLEDGES TO EVALUATE FUTURE OF DIAGNOSTICS REGULATION - POLITICO Prescription Pulse
    At a Medical Device Innovation Consortium fireside chat Thursday, FDA Commissioner Stephen Hahn said the agency will take a fresh look at how it regulates diagnostics and digital technologies after the coronavirus pandemic. The FDA will be working to…
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  • Pandemic pushes FDA to 'accelerate' real-world evidence efforts, Hahn says - MedTech Dive
    FDA is upping efforts to incorporate real-world data in evaluation of COVID-19 diagnostics and antibody tests, announcing Thursday participation in a partnership exploring how to use that data to improve testing quality, better inform…
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  • FDA joins Reagan-Udall, Friends of Cancer Research to form COVID-19 Diagnostics Evidence Accelerator - The Cancer Letter
    FDA is participating in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics.  The accelerator is organized by the Reagan-Udall Foundation for FDA in collaboration…
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  • Accelerating the fight against COVID-19 with real-world data on tests - BioCentury
    Almost every aspect of the fight against COVID-19 depends on the ability to determine whether an individual is or has been infected with SARS-CoV-2, but more than six months into the pandemic there is still uncertainty about the accuracy of widely used…
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  • To expedite progress against COVID-19, a public-private “accelerator” taps into real-world data - The Cancer Letter
    This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.
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  • FDA joins new, public-private COVID-19 diagnostic research accelerator effort - FierceBiotech
    The FDA has joined a public-private diagnostic research project with the goal of bringing more real-world data to bear against the novel coronavirus, and gauging the accuracy of different kinds of tests. Formed by the Reagan-Udall Foundation and Friends…
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  • New accelerator to boost real-world COVID-19 diagnostics - Regulatory Focus
    A collaboration to use real-world diagnostics evidence will seek to answer key questions about the novel coronavirus, including epidemiologic patterns, individual risk factors, and characteristics of immunity that might develop after infection with COVID…
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  • New COVID-19 Diagnostics Evidence Accelerator Applies Real-World Data to Answer Urgent Questions on SARS-CoV-2 Testing
    Today, the Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research, announced the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder, collaborative project to leverage real-world data in the diagnostic test (e.g…
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  • US FDA Looking To Real-World Evidence To Fill in Gaps On COVID-19 Vaccines - Pinksheet
    Principal Deputy Commissioner Amy Abernethy suggests FDA may clear a COVID-19 vaccine on smaller than usual clinical datasets and rely on real-world data to fill in the gaps. Abernethy said a new public-private partnership is starting to explore how it…
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  • The pivotal role of real-world data in a pandemic - Biocentury
    Real-world data is taking on a critical role in the age of COVID-19 drug development, where hasty authorizations are being made on limited datasets and natural history data is being collected in real time. Teams across the industry have stepped up to…
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  • A New Trend in Drug Development: Leveraging Data from Expanded Access - Cancer Therapy Advisor
    A manuscript detailing this study is under revision and awaiting acceptance by the British Journal of Clinical Pharmacology.  The study was funded using an unrestricted grant from myTomorrows, a global company that connects patients to expanded…
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  • WHEN YOU DON’T QUALIFY FOR A CLINICAL TRIAL: EXPANDED ACCESS MIGHT HELP - Triage Cancer
    When dealing with a cancer diagnosis, often times the best form of treatment can be offered through a clinical trial. We de-bunked common myths in this blog post, talking about the benefits of considering clinical trials, in efforts to shift the…
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  • Real-World Data Partnership On COVID-19: US FDA Drawn To Consistency, Diversity of Aetion's Datasets - Pinksheet
    FDA's Amy Abernethy tells the Pink Sheet that initial priorities are likely to include studying COVID-19 natural history and how patients are faring under various medication regimens. Aetion's ability to perform consistent analyses across a variety of…
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  • Coronavirus (COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response
    Today, we are announcing another step in our effort to harness diverse streams of data to understand and respond to COVID-19. The U.S. Food and Drug Administration has entered into an agreement with Aetion to collaborate on advanced analytical techniques…
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  • FDA Teams Up With Data Company Aetion to Study Virus Progression - Bloomberg Law
    The FDA said Tuesday it’s pairing up with the data company Aetion to research Covid-19 complications and what types of medicines virus patients are taking, which could help researchers learn more about which treatments are effective.
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  • FDA, partnering with New York health tech firm, seeks to collect ‘real-world’ data on Covid-19 - STAT
    The Food and Drug Administration said Tuesday that it will launch a new research project focused on real-world evidence — data collected by insurance companies, in electronic health records, and in other places in medicine — to learn more about Covid-19…
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  • A New, Better Normal in Health Care? - National Review
    The COVID-19 crisis has fast-tracked long-contemplated, patient-centric changes in medicine.
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  • BioCentury This Week: Special Edition - Getting Real about COVID-19 Data
    Amy Abernethy, FDA’s principal deputy commissioner and acting CIO, and Mark McClellan, director of the Duke-Margolis Center for Health Policy at Duke University, described in podcast interviews with BioCentury’s Washington Editor Steve Usdin how the…
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  • Health, Defense Agencies Should Cooperate to Beat COVID-19 - RealClearHealth
    The U.S. has been trying to contain COVID-19 through testing and social distancing. Now it’s time to kill it. What’s needed is intragovernmental cooperation, something that, sadly, is rare in the nation’s capital. In this case, Congress and the Trump…
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  • Beyond the Magic Bullet: Medical Progress Is Often Incremental - National Review
    Life won’t completely return to normal while the novel coronavirus remains a threat to health and to life. More than 60,000 Americans have already lost their lives to this virus; while older people seem especially vulnerable, the virus has…
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  • Accelerating the collection of real-world data about COVID-19 - Biocentury
    The Reagan-Udall Foundation and Friends of Cancer Research are trying to put real-world data to use against COVID-19. If there are silver linings to the COVID-19 crisis, one is the way groups and individuals who often have adversarial or competitive…
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  • Politico Prescription Pulse
    Document Drawer The Reagan-Udall Foundation for the FDA and Friends of Cancer Research launched the COVID-19 Evidence Accelerator, a public-private partnership to use data analytics to understand the virus.
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  • Real-World Evidence On COVID-19: US FDA Approaching With 'Sense Of Urgency' - Pink Sheet
    "Identifying key questions and core data elements is at the heart of a new initiative launched by the Reagan-Udall Foundation and Friends of Cancer Research. The COVID-19 Evidence Accelerator provides a venue for major data organizations, government and…
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  • First Look at Gilead Drug Virus Response to Open Data Floodgates - Bloomberg Law
    "A new initiative called the COVID-19 Evidence Accelerator aims to pool ongoing data sources from government and academic researchers, health systems, and private companies to solut
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  • COVID-19 Evidence Accelerator Leverages Real-World Evidence in FDA’s Response to Global Pandemic
    The Reagan-Udall Foundation for the FDA (Foundation) in collaboration with Friends of Cancer Research (Friends) today announced the COVID-19 Evidence Accelerator, an expansive public-private partnership combining the efforts of academic, government, and…
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  • One-Stop Resource Helps Patients and Healthcare Providers Link to COVID-19 Clinical Trials and Expanded Access Programs
    To help patients, caregivers, physicians, and other healthcare providers find COVID-19 treatment resources as quickly and easily as possible, the Reagan-Udall Foundation for the FDA today launched the online COVID-19 Treatment Hub.
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  • Reagan-Udall Foundation for the FDA Names Susan Winckler as CEO
    The Reagan-Udall Foundation for the Food and Drug Administration has named Susan C. Winckler, RPh, Esq., former FDA Chief of Staff, as its Chief Executive Officer. She will assume the role on May 1, 2020.
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  • Food Industry Leader Molly Fogarty Named to Board of Directors
    Molly Fogarty, Senior Vice President of Nestlé in the U.S., has been appointed to the Board of Directors for the Reagan-Udall Foundation for the Food and Drug Administration.
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  • Nominations now closed
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  • 2019 Innovations in Regulatory Science Awards Dinner Highlights
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  • Winners of 2019 Innovations in Regulatory Science Awards Announced
    FDA’s Theresa Mullin, Compassionate Use Advisory Committee, and Cystic Fibrosis Foundation to be Honored with Innovations in Regulatory Science Awards  Honorees to be recognized on December 11 in Washington, DC Washington, DC - The Reagan-Udall…
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  • Duke's Hernandez Appointed to Reagan-Udall Foundation Board of Directors
    The Reagan-Udall Foundation for the Food and Drug Administration has named Dr. Adrian F. Hernandez to its Board of Directors.
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  • Reagan-Udall Foundation for the FDA invites Nominations for IMEDS Steering Committee
    The Reagan-Udall Foundation for the FDA seeks nominations for key positions on its Steering Committee. Comprised of 12 members, the IMEDS Steering Committee provides oversight and guidance on the operation of IMEDS by advising on strategic…
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  • FDA Eases Access to Unapproved Cancer Drugs - OBR Daily
    "Patients with cancer are treated with drugs already approved by the U.S. Food and Drug Administration (FDA) or with an investigational agent in a clinical trial. But there are some patients who may need access to investigational drugs outside the realm…
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  • Project Facilitate: FDA’s Plan to Ease Expanded Access to Novel Therapies - The ASCO Post
    The U.S. Food and Drug Administration (FDA) plans to provide oncologists with greater help in acquiring expanded access to investigational therapies. Deemed Project Facilitate, the pilot program was announced at a press briefing during the 2019 ASCO…
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  • FDA Launches Expanded Access Pilot ‘Project Facilitate’ - Regulatory Focus
    The US Food and Drug Administration (FDA) on Monday launched a new pilot program, dubbed Project Facilitate, aimed at helping physicians complete expanded access requests for cancer patients.  
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  • FDA, Reagan-Udall launch end-to-end expanded access program for cancer - BioCentury
    FDA's Oncology Center of Excellence and the Reagan-Udall Foundation launched Expanded Access Navigator and Project Facilitate, two separate but coordinated pilot programs to provide patients and physicians with expanded access to oncology drugs. The…
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  • Enhancements to EA Navigator Improve Patient Access to Investigational Therapies
    Embargoed until 9 a.m. EDT June 3, 2019 Media Inquiries: Lea Ann Browning-McNee, 301-509-1846 Consumer/Provider Inquiries: 202-849-2075 Expanded Access Navigator Improves Patient Access to Investigational Therapies New enhancements make it easier for…
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  • Sharpless Calls for a Nimble, Flexible, More Efficient US FDA - Pinksheet
    "Sharpless said FDA's organization also must ensure collaboration across disciplines and locations, as well as with outside groups. In a speech to the Reagan-Udall Foundation annual meeting later in the day, though, he acknowledged that outside…
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  • Sharpless Begins to Learn the Ropes While FDA Center Directors Look to the Future
    Read Zach Brennan’s reference to the Foundation's Annual Public Meeting in his Regulatory Focus™ article:  “Sharpless Begins to Learn the Ropes While FDA Center Directors Look to the Future”
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  • Wasser Departs Reagan-Udall Foundation for the FDA
    June Wasser Departs Reagan-Udall Foundation for the FDA Amar Bhat, PhD, named Interim Executive Director
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  • Call for Nominations: Innovations in Regulatory Science Awards
    Reagan-Udall Foundation for the Food and Drug Administration is seeking nominations through June 14, 2019, for its third annual Innovations in Regulatory Science Awards. These Awards honor outstanding achievements of individuals and organizations…
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  • Report on Leveraging Real-World Treatment Experience from Expanded Access Protocols
    Learn about strategies for Leveraging Real-World Treatment Experience from Expanded Access Protocols in the report from our November public meeting at the FDA White Oak Campus. We brought all the stakeholders together --- patient advocates, physicians,…
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  • Updated FDA Guidance on Expanded Access
    The FDA updated its guidance to clarify that listing in our Expanded Access Navigator Company Directory satisfies the 21st Century Cures Act requirement of making EA policies readily available. Read "How should we post our expanded access policy?" …
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  • CDER 2018 Drug Safety Priorities Report
    New Drug Safety Priorities Report for 2018 highlights CDER’s safety work with a reference to our IMEDS program that "allows public and private entities access to the Sentinel System.”  
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  • FDA to facilitate access to unapproved drugs
    Biocentury coverage on the FDA’s expanded access program and collaboration with the Reagan-Udall Foundation is available here: https://www.biocentury.com/biocentury/regulation/2018-12-14/how-fda-plans-help-patients-get-expanded-access-unapproved-drugs
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  • The FDA Sentinel Initiative: An evolving National Resource
    Read The FDA Sentinel Initiative—An Evolving National Resource pubished in New England Journal of Medicine in November 2018 by Platt et al featuring our IMEDS program. 
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  • Coming soon for Expanded Access Policies
    Updates are coming to expanded access procedures and data use. Read the latest from FDA Law Blog featuring key messages from our public meeting on leveraging expanded acccess data.
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  • Expanded Access Data Can Support Approval Decisions, US FDA Says
    Pink Sheet featured an article authored by Kate Rawson which highlights important takeaways from our public meeting, Leveraging Real-World Treatment Experience from Expanded Access Protocols on November 19, 2018 at the FDA White Oak Campus. Find the…
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  • Reagan-Udall Foundation for the FDA Announces Appointment of Three New Board Members
    The Reagan-Udall Foundation for the Food and Drug Administration expands its leadership with the appointment of three new Board members: Andrew C. von Eschenbach, M.D., former FDA Commissioner; Edward John Allera JD, pharmacist and attorney with…
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  • Winners of 2018 Innovations in Regulatory Science Awards Announced
    We're excited to honor two longtime U.S. Food and Drug Administration leaders and an independent public-private partnership as the 2018 recipients of the Innovations in Regulatory Science Awards to be honored on December 4, 2018.
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  • Wasser Joins Hands On Classrooms Advisory Panel
    Our Executive Director June S. Wasser has agreed to serve on the advisory panel for a new initiative of the Grocery Manufacturers Association Science and Education Foundation (GMA SEF). In this capacity Wasser will be an external reviewer of the next…
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  • Real-World Evidence to Increase Value in Health Care
    Mark McClellan and his colleagues at Duke-Margolis Health Policy Center outline how real-world evidence can increase value in health care in this Growth Commentary referencing Reagan-Udall Foundation for the FDA’s IMEDS program.
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  • Reagan-Udall Foundation at the 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE)
    During the ICPE conference, our Executive Director, June Wasser, will be discussing the importance of the Foundation’s IMEDS (Innovation in Medical Evidence Development and Surveillance) program, which provides a framework and entry point for private-…
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  • Call for Nominations to Honor Regulatory Science Leaders
    The Reagan-Udall Foundation for the Food and Drug Administration is pleased to announce the call for nominations for the 2018 Innovations in Regulatory Science Awards. The Foundation will be honoring the leadership and achievements of those…
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  • FDA Commissioner Previews OND Changes at Annual Meeting
    Dr. Scott Gottlieb indicated that the upcoming changes to the FDA Office of New Drugs would likely be in place this summer, when taking questions at the Foundation's Annual Public Meeting in this article from RAPS.
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  • IMEDS Panel Presentation at DIA Global Annual Meeting 2018
    Stop by booth #622 to learn more about the Foundation and our programs including, Innovation in Medical Evidence Development and Surveillance (IMEDS), the Expanded Access Navigator, and our Fellowship initiative.
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  • Pre-approval Access Webinar
    The Reagan-Udall Foundation for the FDA's Executive Director, June Wasser, was a presenter on a June 6th webinar sponsored by Johnson & Johnson and NYU Langone Health. She explained how patients use the Foundation's Expanded Access…
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  • Panel of Commissioners Discuss Evolution of FDA at Foundation's Public Meeting May 4th
    Each year the Foundation conducts an annual meeting, open to the public, to discuss its activities and how it supports FDA. This year's meeting takes place May 4th, from 10 a.m until noon, at the law offices of Alston and Bird (950 F St. NW, Washington,…
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  • 2018 Annual Public Meeting
    We have reached room capacity so registration to attend the meeting is now closed. We look forward to seeing those who registered before April 19th and thank everyone for your support of the Reagan-Udall Foundation for the FDA. The public is…
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  • Press release on Expanded Access Navigator after "right-to-try" vote
    DATELINE: WASHINGTON D.C. - MARCH 22, 2018 Right-To-Try law not a shortcut to investigational drugs – Expanded Access Navigator can reduce confusion. Serious or terminally ill patients hoping House passage of federal Right-To-Try legislation will…
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  • Navigator presentation at CBI's Expanded Access Programs 2018
    Executive Director June Wasser's talk on the Evolving Scope of the Expanded Access Navigator starts at 11am, Wednesday March 28th and includes an update on its expansion into rare diseases. This year's Expanded Access Programs focus is "Design…
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  • Rare Disease Day at NIH
    Stop by the foundation's table at NIH's Rare Disease Day on March 1st for a demonstration of the Expanded Access Navigator. It's a website that focused initially on oncology but is adding resources for the rare disease community in 2018.
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  • FDA News Picks Up on Foundation Fellowships as Workforce Multiplier
    FDA hopes to bolster its scientific staff in 2018 and this piece in FDA News explains how the Reagan-Udall Foundation's upcoming Fellowship program could funnel talented post-docs into the agency it was created to support. 
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  • Sentinel workshop and next-day training
    New analytic tools and methods enhancements have unlocked access to more diverse sources of data than ever before, improving the quality of evidence for safety surveillance. That’s why each year FDA and key leaders from across the Sentinel System…
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  • Senator Enzi's Gala Remarks Reach Back to Foundation's Start
    Senator Mike Enzi's remarks reminded attendees that Congress named the Reagan-Udall Foundation for the FDA after two leaders fighting neurodegenerative disorders.
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  • Press release announcing winners of Innovations in Regulatory Science Awards
    The secret's out, and we're excited to honor the two leaders who will be receiving the inaugural Innovations in Regulatory Science Awards at the Gala December 5th. Here's the press release we shared with media and sponsors.
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  • Mission and Programs Presentation
    Curious about public-private partnerships and the Reagan-Udall Foundation for the FDA? Happy to schedule a presentation on our history, vision, mission and opportunities.
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  • Save the Date for 2017 Gala
    Inaugural Reagan-Udall Foundation for the FDA Innovations in Regulatory Science Awards Gala  Image
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  • FDA Commissioner announces Navigator expansion to Rare Diseases
    In one powerful blog post, Dr. Gottlieb waives requirements to wait for a full convening of IRBs to approve single patient expanded access treatments, announces the future expansion of the Foundation's Navigator to rare diseases and offers clarity…
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  • Keynote Address at Indiana Life Sciences Summit
    Find our how the Foundation got its start and where it's headed at the Indiana Life Sciences Summit in Indianapolis. Executive Director June Wasser presents a keynote address on the Foundation's mission and public-private partnerships on Tuesday, 10…
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  • Innovation Awards Nomination Forms
    Nominations are now being accepted for the Innovations in Regulatory Science Awards. These awards will be presented at the inaugural Innovations in Regulatory Science Awards Gala on December 5th, 2017 at the Kaiser Permanente Center for Total Health in…
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  • The Expanded Access Navigator to be Featured at Philadelphia's Pre-Approval Access Conference
    Executive Director June Wasser leads a 1:45pm session Tuesday, 9/26 on how the Navigator started and resources it shares with patients and physicians.
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  • Fox News Tampa's Dr. Jo Calls Navigator an Exciting Advancement
    Dr. Joette Giovinco shared the launch of the Expanded Access Navigator in a Fox Medical Team TV and online report. She credited the FDA and advocacy groups who provided input for the online tool and the clip shows how companies are listing single patient…
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  • Learn About IMEDS at ICPE in Montreal
    The Foundation welcomes questions and discussion about IMEDS at the 33rd International Conference on Pharmacoepidemiology and Therapeutic Risk Management Aug 26-30. Stop by Booth 45 for a personal discussion of IMEDS capabilities.
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  • Press Release Launching Expanded Access Navigator
    Dateline: Washington, D.C. The Reagan-Udall Foundation for the FDA launches Navigator website to share resources and policies on expanded access to investigational therapies.
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  • Forbes article explains how the Navigator helps doctors request expanded access
    Saving time is critical for physicians treating seriously ill patients who have exhausted alternatives to expanded access. So Forbes contributor Alison Bateman-House explains how the Navigator spells out timelines in this piece called "How To Try An…
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  • STAT features Navigator article by Exec. Dir. June Wasser
    In the article, Wasser explains why the FDA asked its foundation to create a public-private partnership launching the Navigator. Legislation like the 21st Century Cures Act and changes in regulation require drug companies to make any expanded access…
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  • MedPage Today describes the Navigator's 8 steps for expanded access
    This short MedPage article focuses on the Navigator's step-by-step guided experience for patients and physicians: from identifying treatment and exploring clinical trials to seeking IRB approval and treatment/reporting requirements.
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  • DIA Global Forum article traces roots of IMEDS
    Executive Director June Wasser explains the evolution of IMEDS, the Foundation's public-private, big-data partnership modeled after FDA's Sentinal program.
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  • Denver Post notes Navigator as an FDA improvement in article about Right-To-Try
    The Post and other publications picked up CQ-Roll Call's Andrew Siddons' analysis of the potential impact of federal Right-To-Try legislation. Read the article here: the Reagan-Udall Foundation and Navigator are part of the concluding…
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  • FDA Blog kicks off industry coverage of Navigator launch
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  • Susan G. Komen calls Navigator a lifeline
    In this article, Interim President and CEO Ellen Willmot shares her hope that the Navigator will make it easier for breast cancer physicians and patients to apply for, and benefit from, expanded access to investigational treatments
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  • Navigator's Oncology Focus Cited by ASCO
    The American Society of Clinical Oncology helped develop the Navigator and in this post describes it as a clearinghouse for the single-patient expanded access policies of dozens on leading biopharmaceutical companies. 
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  • The Health Care Blog Shares Uses for Navigator
    This post points out that the Navigator will expand from an oncology focus to other therapeutic areas in the future, and walks through a hypothetical Zika case where clear expanded access information would be critical.
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  • Pharmaceutical Commerce links Gottlieb to Navigator's aims
    This magazine article says the Navigator streamlines information-gathering and links the launch to FDA Commissioner Scott Gottlieb's statements that the expanded access process should be less expensive and time-consuming.
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  • Biotech-Now Urges Companies to Use Navigator Directory
    This blog from the Biotechnology Innovation Organization reminds companies they can comply with the 21st Century Cures Act’s requirements to make their expanded access policy publicly available by listing it on the Expanded Access…
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  • Infodocket Credits Team Effort for Navigator
    Quoting the FDA Voice Blog, this online post mentions the Navigator's public-private partners who help guide patients and physicians through the expanded access process.
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© Reagan-Udall Foundation for the FDA