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Series:Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Draft Guidance for Industry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
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.
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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.
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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.
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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.
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.
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…
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.
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. Food and Drug…
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). …
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 it…
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 Congress…
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…
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 Program and Office of…
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.
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.
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.
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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.
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(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…
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 distribution,…
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 structure and culture, The…
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.
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Last month, the Reagan-Udall Foundation delivered a damning review of the Food and Drug Administration’s (FDA) performance as a tobacco regulator.
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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?
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The Food and Drug Administration last year failed repeatedly to keep the nation’s babies safe from tainted formula. The baby formula fiasco was the latest in a long line of food crises that the agency was slow to catch and handle.
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”…
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…
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.
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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 one big…
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 be a much better deal if the agency…
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.
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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).
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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.
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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 Silvis.…
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 FDA Chief…
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.
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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…
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…
(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…
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…
(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…
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…
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.
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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…
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 in…
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…
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 Foods Program…
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 sought the…
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-related group…
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…
(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…
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…
(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…
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 for…
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.
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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.
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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.
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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…
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 (CTP…
(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…
(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 recognize…
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 experts today.…
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…
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 members of a…
(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.
“We want…
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 operations at…
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…
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…
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.
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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,…
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.
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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…
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…
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 patient and advocacy…
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…
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 data in…
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…
(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…
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.
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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…
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 meeting of its…
(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.
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, urging…
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…
(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,…
(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…
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…
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…
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.
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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.
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(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…
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.
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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,…
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.
“Fundamental questions…
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
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…
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…
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…
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.
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 agency…
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 issues…
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…
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.
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 company to…
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 performance of…
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…
Exploring the Potential for a Public-Private Partnership to Support the Tracking and Monitoring of Antimicrobial Use in Food-Producing Animals
Virtual Public ForumTuesday, June 14, 20221-3pm Eastern Time
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…
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,…
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…
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…
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…
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. This…
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…
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-…
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…
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…
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 period…
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.
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…
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 Foundation for…
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…
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).
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…
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 the…
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.…
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 one of only two…
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.
(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 $…
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 we…
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@reaganudall…
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
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.
Read more here.
(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…
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
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…
Real-World Data Webinar Series:Data Standards for Drug and Biological Product Submissions Containing Real-World Data – Draft Guidance for IndustryFriday, December 3, 2021
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
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% of eligible…
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 Patrick J. Kennedy.
(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.
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…
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 disseminate…
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…
(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…
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…
(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…
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.…
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,…
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…
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 directed…
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 joined…
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…
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…
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…
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…
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…
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…
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…
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…
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 for…
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…
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.
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…
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…
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…
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
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
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…
(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…
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.
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
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 bodily…
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…
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…
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…
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, and …
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…
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.
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…
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 organization ever to…
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.
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…
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…
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 trials…
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…
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.
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 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,…
"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 for…
"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”
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…
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.
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…
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…
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…
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.
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…
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.
