- 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…
- 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…
- 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…
- 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 –…
- 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 effectiveness.
- 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…
- 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…
- 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…
- 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.
- 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…
- 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…
- 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
- 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…
- 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…
- 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…
- 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 before has…
- 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…
- “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…
- 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 Committee,…
- 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…
- 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…
- 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.…
- 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-…
- 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…
- 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…
- 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…
- 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:
- 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…
- 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…
- 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
- 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…
- 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 population testing…
- 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 with Friends…
- 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…
- 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.
- 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…
- 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…
- 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…
- 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…
- 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…
- 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 access…
- 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…
- 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…
- 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…
- 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.
- 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…
- The COVID-19 crisis has fast-tracked long-contemplated, patient-centric changes in medicine.
- 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…
- 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…
- 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 demonstrated…
- 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…
- 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.
- "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…
- "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 solutions for C
- 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…
- 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.
- Nominations are now open for the 2020 Innovations in Regulatory Science Awards presented annually by the Reagan-Udall Foundation for the Food and Drug Administration. These Awards celebrate outstanding achievement in regulatory science and policy.…
- 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.
- 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.
- 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…
- The Reagan-Udall Foundation for the Food and Drug Administration has named Dr. Adrian F. Hernandez to its Board of Directors. Dr. Hernandez brings extensive clinical and research experience to the Foundation’s leadership, having served as the Principal…
- 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 direction,…
- 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…
- 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.
- "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…
- 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…
- 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.
- 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…
- 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…
- Image Talk to our experts at Booth 625 during the DIA 2019 Global Annual Meeting in San Diego. The Exhibit Hall opens June 24.
- "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…
- 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”
- June Wasser Departs Reagan-Udall Foundation for the FDA Amar Bhat, PhD, named Interim Executive Director
- 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 Register Here
- 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 that…
- 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…
- 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,…
- 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?" for…
- 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.”
- 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
- 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.
- 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.
- 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: Defining challenges and…
- 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…
- 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…
- 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 20993
- 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…
- 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.
- 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…
- 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
- 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.
- 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-…
- 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 whose work…
- 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…
- 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.
- 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.
- 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 Navigator. The…
- 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,…
- 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 still …
- 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…
- 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…
- 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.
- 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.
- 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…
- Senator Mike Enzi's remarks reminded attendees that Congress named the Reagan-Udall Foundation for the FDA after two leaders fighting neurodegenerative disorders.
- 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.
- 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.
- Inaugural Reagan-Udall Foundation for the FDA Innovations in Regulatory Science Awards Gala Image
- 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 on…
- 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, 10/10.
- 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…
- 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.
- 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…
- 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.
- 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.
- 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…
- 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…
- 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.
- Executive Director June Wasser explains the evolution of IMEDS, the Foundation's public-private, big-data partnership modeled after FDA's Sentinal program.
- 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 paragraphs about…
- 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
- 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.
- 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.
- 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.
- 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 Navigator's Company…
- 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.
