Skip to main content
Home
  • About
    • Board of Directors
    • Our Staff
    • Annual Reports
      • 2018 Annual Report
      • 2021 Annual Report
      • 2017 Annual Report
    • Policies
    • Careers
    • Programs
      • COVID-19 Hub
      • Antimicrobial Use Data in Food Animals
      • Food & Nutrition
      • Research
        • About IMEDS
        • IMEDS Network Partners
        • IMEDS Populations
        • IMEDS Steering Committee
        • Post Market Research
        • Real World Evidence
        • Real-World Data Webinars
        • IMEDS News Archive
      • Expanded Access Navigator
      • Substance Use Disorders
      • FDA Patient Listening Sessions
    • News and Events
      • 2022 Annual Public Meeting
      • News
      • Events
      • Innovations in Regulatory Science Awards
    • COVID-19
    • facebook
    • twitter
    • linkedin
    • youtube
    Home
    • About
      • Board of Directors
      • Our Staff
      • Annual Reports
      • Policies
      • Careers
    • Programs
      • COVID-19 Hub
      • Antimicrobial Use Data in Food Animals
      • Food & Nutrition
      • Research
      • Expanded Access Navigator
      • Substance Use Disorders
      • FDA Patient Listening Sessions
    • News and Events
      • 2022 Annual Public Meeting
      • News
      • Events
      • Innovations in Regulatory Science Awards
    • COVID-19

    News and Events

    Breadcrumb

    1. Home
    • Announcements
    • Coverage
    • Events
    • Annual Public Meeting
    • Awards
    • Wednesday, August 03, 2022
      Big shakeups under way in much-criticized U.S. health agencies - JD Supra
      While most regular folks wouldn’t give a hill of beans about the organization of bureaucracies in Washington, D.C., frustrated taxpayers should be taking note of seismic rumblings about restructurings that are shaking some of the biggest, most powerful,…
      Read More
    • Tuesday, August 02, 2022
      Inside FDA’s big food reboot - Food Fix
      When FDA announced last month it had commissioned an outside evaluation of its foods program (as well as tobacco), it was seen by many as a formal, if somewhat tepid, admission that something had gone very wrong at the agency. “Fundamental questions…
      Read More
    • Thursday, July 21, 2022
      FDA Head Orders a Review of Its Nicotine Division, to Mixed Response - Filter
      On July 20, Robert Califf, the head of the Food and Drug Administration (FDA), announced that he would commission external experts to conduct “a comprehensive evaluation” of the agency’s food and nicotine divisions. Read more
      Read More
    • Thursday, July 21, 2022
      FDA confronts ‘sub-optimal environment’ for food safety with ‘top to bottom’ review - Food Navigator
      Facing sharp criticism in the media that FDA’s approach to food safety is “broken,” “Byzantine” and a “ridiculous joke,” the agency is undertaking a “top to bottom” review of the “structure, function, funding and leadership” of its food program, agency…
      Read More
    • Thursday, July 21, 2022
      Therapeutics/Vaccines Lab Meeting
      Join us Thursday, July 21 at 3 pm ET for the July Therapeutics & Vaccines lab Meeting. We’ll be hearing from Elizabeth Eldridge of Health Catalyst. Liz will be describing the new research project they are taking on at the request of the Evidence…
      Read More
    • Thursday, July 21, 2022
      Diagnostics Lab Meeting
      Join us Thursday, July 21 at noon ET to hear from Dr. Keith Campbell of FDA's Center for Devices and Radiological Health. He'll be speaking about Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD), a public-private…
      Read More
    • Wednesday, July 20, 2022
      FDA weighs oversight changes after formula, Juul troubles - Associated Press
      The head of the Food and Drug Administration has asked for a review of the agency’s food and tobacco programs following months of criticism over their handling of the baby formula shortage and e-cigarette reviews.
      Read More
    • Wednesday, July 20, 2022
      F.D.A. Seeks Outside Review of Troubled Food and Tobacco Units - New York Times
      The Food and Drug Administration has commissioned a review of its food and tobacco programs following public outrage over baby formula  shortages and concerns about flavored nicotine products. Dr. Robert Califf, the head of the F.D.A., said the agency…
      Read More
    • Tuesday, July 19, 2022
      Amid controversies, FDA seeks advice on food and tobacco operations - The Washington Post
      The head of the Food and Drug Administration said Tuesday he is asking outside experts to conduct a comprehensive evaluation of the agency’s food and tobacco programs, which in recent months have endured sharp criticism involving two high-profile issues…
      Read More
    • Tuesday, July 19, 2022
      FDA Conducting Evaluation of Key Agency Activities to Strengthen Operations
      In February 2022, I rejoined the U.S. Food and Drug Administration as Commissioner of Food and Drugs, having served in the role five years earlier. Since my return, the agency has taken many significant actions that benefit the public health. Yet at the…
      Read More
    • Tuesday, July 19, 2022
      FDA announces external review of food safety and tobacco regulatory offices - POLITICO
      Food and Drug Administration Commissioner Robert Califf said on Tuesday that he has ordered an external review of the agency’s offices on food safety and tobacco regulation.
      Read More
    • Tuesday, July 19, 2022
      FDA leader hiring affiliated foundation to review problems at food side of agency - Food Safety News
      A shakeup of the chain of command at the FDA may be coming, but the beginning of the release of details is at least 60 working days away. FDA Commissioner Dr. Robert Califf told Food Safety News today that the agency has hired an outside company to…
      Read More
    • Thursday, June 16, 2022
      Therapeutics/Vaccines Lab Meeting
      Beyond the learning acceleration of our COVID-19 Evidence Accelerator lab meetings, the Evidence Accelerator model includes “engines” of evidence generation. At the June 16th Therapeutics and Vaccines meeting, we’ll review the results and performance of…
      Read More
    • Thursday, June 16, 2022
      Diagnostics Lab Meeting
      Join the COVID-19 Diagnostics Evidence Accelerator  to check-up on what’s happening with the Mayo Clinic. Since Mayo’s (and their research partners at Yale University) participation in our research project looking at use patterns and performance of…
      Read More
    • Tuesday, June 14, 2022
      Tracking and Monitoring of Antimicrobial Use in Food-Producing Animals
      Exploring the Potential for a Public-Private Partnership to Support the Tracking and Monitoring of Antimicrobial Use in Food-Producing Animals Virtual Public Forum Tuesday, June 14, 2022 1-3pm Eastern Time
      Read More
    • Wednesday, June 01, 2022
      Alzheimer’s Evidence Accelerator Modeled On FDA COVID Project Floated By USAgainstAlzheimer’s - Pink Sheet
      Patient organization exploring development of a multi-stakeholder forum on real world evidence that, among other things, could address research questions posed by the Centers for Medicare and Medicaid Services in its national coverage determination for…
      Read More
    • Thursday, May 19, 2022
      Therapeutics/Vaccines Lab Meeting
      This month we will learn more about the opportunity to ‘listen’ for safety signals in social media from the Sanofi Digital team, as they share some of their advanced analytics and visualization regarding what is being said about COVID vaccine safety,…
      Read More
    • Thursday, May 19, 2022
      Diagnostics Lab Meeting
      In this month's Diagnostics Lab meeting, we will be hearing from two groups working to enable the flow of health information throughout numerous vendors, implementers, networks and governance frameworks. We’ll hear first from Mariann Yeager, CEO of The…
      Read More
    • Tuesday, May 17, 2022
      2022 Annual Public Meeting
      More than 200 patient, consumer, industry, research, and government stakeholders joined the Foundation’s Annual Public Meeting of our Board of Directors on May 16, 2022. The event featured candid discussions with senior FDA leadership on topics ranging…
      Read More
    • Tuesday, May 17, 2022
      Woodcock Weighs in on ARPA-H - POLITICO's Prescription Pulse
      If the proposed Advanced Research Projects Agency for Health is created, new treatment candidates would need to engage with FDA early on to help determine appropriate clinical testing design, FDA principal deputy commissioner Janet Woodcock said Monday…
      Read More
    • Monday, May 16, 2022
      2022 Annual Public Meeting
      2022 Annual Public Meeting May 16, 2022 2:30-4 PM Eastern Each year, the Reagan-Udall Foundation for the FDA conducts an Annual Public Meeting of its Board of Directors to share its activities in support of the U.S. Food and Drug Administration. This…
      Read More
    • Tuesday, May 03, 2022
      Global Genes and the Orphan Disease Center of the University of Pennsylvania Host 7th Annual RARE Drug Development Symposium - Yahoo Finance
      -Global Genes, a leading rare disease patient advocacy organization, today announced its 7th annual 
      Read More
    • Thursday, April 21, 2022
      Evidence Accelerator: Therapeutics/Vaccines Lab Meeting
      The topic for this month's Therapeutics/Vaccines Lab Meeting is "Test to Treat." This is our once-monthly COVID-19 Evidence Accelerator Therapeutics/Vaccines Lab Meeting. This meeting is held the third Thursday of every month at 3pm ET. If you are…
      Read More
    • Thursday, April 21, 2022
      Evidence Accelerator: Diagnostics Lab Meeting
      This month's Diagnostics Lab meeting we will look at LAMP-based diagnostics; Testing in the airline industry and air travel. We will hear presentations from Dr. Nilay Shah of Delta Airlines and Randy True of FloodLamp Biotechnologies. This is the once-…
      Read More
    • Monday, April 04, 2022
      Save the Date! Innovations in Regulatory Science Awards Will be Held December 6
      Save the date and please join us for the 2022 Innovations in Regulatory Science Awards presented on December 6th at the Mayflower Hotel. Watch this space for information about the awards event. The awards are presented annually by the Reagan-Udall…
      Read More
    • Thursday, March 31, 2022
      FDA says IT modernization came at right time for COVID - Regulatory Focus
      While the US Food and Drug Administration (FDA) began the process of modernizing its IT systems before the COVID-19 pandemic, the crisis accelerated much of that work and allowed the agency to streamline much of its activities at a critical moment in…
      Read More
    • Wednesday, March 30, 2022
      FDA’s Technology and Data Modernization in Action in 2022
      In partnership with the Reagan-Udall Foundation, the FDA and the Friends of Cancer Research launched the Evidence Accelerator (EA) to advance the use of Real-World Data (RWD) to inform the COVID-19 response. In collaboration, ODT and the FDA’s Office of…
      Read More
    • Wednesday, March 30, 2022
      Make Naloxone More Accessible to At-Risk Americans, Experts Say - MedPage Today
      Strategies to expand access to naloxone (Narcan) for the prevention of opioid overdoses were explored during a webinar hosted by the Reagan-Udall Foundation for the FDA on Tuesday. Over 100,000 people died from drug overdoses over a 12-month period…
      Read More
    • Tuesday, March 29, 2022
      Naloxone Access: Answering Questions
      Naloxone Access: Answering Questions Virtual Public Meeting  Tuesday, March 29, 2022 12:30 – 3 PM Eastern Time
      Read More
    • Friday, March 18, 2022
      FDA to Convene Workshop on Naloxone Access - POLITICO's Prescription Pulse
      FDA and the Reagan-Udall Foundation will hold a virtual meeting on March 29 to discuss strategies to increase access to naloxone, the opioid overdose reversal drug. Read the full story here.
      Read More
    • Thursday, March 17, 2022
      Naloxone Access: Answering Questions
      What: The Reagan-Udall Foundation for the FDA (FDA Foundation), in collaboration with the U.S. Food and Drug Administration, is hosting a virtual public meeting to explore questions about access to naloxone, a drug used to reverse opioid overdoses. Harm…
      Read More
    • Thursday, March 17, 2022
      FDA, Reagan-Udall Foundation for the FDA to Hold Important Public Workshop to Discuss Naloxone Access
      The U.S. Food and Drug Administration will host a virtual public workshop on Mar. 29, to discuss critical questions around access to naloxone, a drug used to reverse opioid overdoses. The workshop is a collaboration with the Reagan-Udall Foundation for…
      Read More
    • Thursday, March 17, 2022
      Evidence Accelerator: Therapeutics/Vaccines Lab Meeting
      During this week's Therapeutics/Vaccines Lab meeting we will host an interview moderated by Duke University's Dr. Murali Doraiswamy. During the interview, Dr. Doraiswamy will speak with Dr. Patrizia Cavazzoni of FDA's Center for Drug Evaluation and…
      Read More
    • Thursday, March 17, 2022
      Evidence Accelerator: Diagnostics Lab Meeting
      This week's Diagnostics Lab Meeting will feature presentations focused on tying diagnostics and therapeutics, using patient-level variant testing to determine availability of certain monoclonal antibodies (mAbs).
      Read More
    • Wednesday, March 16, 2022
      US FDA Tries To Shape The Accelerated Approval Reform Narrative - Pink Sheet
      US Food and Drug Administration officials appear to want stakeholders, and maybe more importantly, lawmakers, to let go of the notion that failure is not an option with accelerated approval. “There is going to be uncertainty regarding whether the drug…
      Read More
    • Friday, March 11, 2022
      Accelerated Approval Program Virtual Public Meeting
      The Accelerated Approval Pathway was created by Congress to allow patients with a serious or life-threatening disease earlier access to a potentially important treatment. At this virtual public meeting we explored the insights and lessons learned in the…
      Read More
    • Thursday, March 10, 2022
      Meharry’s Dr. Hildreth Joins FDA Foundation Board- The Tennessee Tribune
      The Reagan-Udall Foundation for the Food and Drug Administration (FDA Foundation) has appointed four new Board members: David C. Fajgenbaum, MD, MBA, MSc, FCPP, University of Pennsylvania; William N. Hait, MD, PhD, Johnson & Johnson; James E.K.…
      Read More
    • Tuesday, March 08, 2022
      Chelsea Project Tapped for $893,500 Rapid-Testing Research Grant - The Digital Journal
      Two organizations with roots at MIT have joined forces to improve our understanding and use of rapid antigen tests in real-world settings. IDx20, headed by MIT scientist Irene Bosch, together with the Chelsea Project are the recipients of one of only two…
      Read More
    • Monday, March 07, 2022
      Reagan-Udall Foundation for the FDA Announces New Board Members
      (March 7, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) has appointed four new members to our Board of Directors: 
      Read More
    • Tuesday, March 01, 2022
      A major boost for NIH and FDA’s private-sector partnerships - STAT News
      Congress is dramatically increasing the amount of money that the NIH and FDA spend on research partnerships with the private sector — namely, collaborations with drug and device companies.
      Read More
    • Tuesday, March 01, 2022
      Reagan-Udall Foundation for the FDA Awards $1.8 Million in Research Funding for Studies on the Real-World Performance of COVID-19 Tests
      (March 1, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) awarded $1.8 million in funding for two research projects evaluating the Real-World Performance of In Vitro Diagnostics (PIVD). Beth Israel Deaconess Medical Center will receive $…
      Read More
    • Thursday, February 17, 2022
      COVID-19 Evidence Accelerator: Therapeutics/Vaccines Lab Meeting
       02/17/2022 - 03:00 PM During our February Therapeutics/Vaccines Lab Meeting we will hear from colleagues at WHO and Gavi, TriNetX, and Kaiser Permanente California discuss ongoing vaccine research. Nevine Zariffa will also join us to discuss what we…
      Read More
    • Thursday, February 17, 2022
      COVID-19 Evidence Accelerator: Diagnostics Lab Meeting
      This is the once-monthly COVID-19 Evidence Accelerator Diagnostics Lab Meeting. These meetings occur the third Thursday of every month at 12 pm ET.  If you are interested in attending the meeting series please email us at evidenceaccelerator@reaganudall…
      Read More
    • Friday, February 11, 2022
      Real-World Data Webinar Series: Considerations for the Use of RWD and RWE
      Real-World Data Webinar Series: Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products (Guidance for Industry) Friday, February 11, 2022 11 AM-12 PM Eastern  
      Read More
    • Friday, February 04, 2022
      This Week at FDA
      The Reagan-Udall Foundation for the FDA published a report today that looks into the lessons learned about the clinical evaluation of therapeutics for COVID-19. The 21-page report is based on discussions from a workshop last September.  Read more here.
      Read More
    • Friday, February 04, 2022
      Reagan-Udall Foundation for the FDA Issues Paper on COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics
      (February 4, 2022) The Reagan-Udall Foundation for the FDA, at the request of the U.S. Food and Drug Administration, has released a report that outlines initial lessons learned from the federal government’s and research communities’ COVID-19 response and…
      Read More
    • Friday, January 28, 2022
      Real-World Data Webinar Series: Registries
      Real-World Data Webinar Series: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products (Guidance for Industry) Friday, January 28, 2022 1-2 PM Eastern
      Read More
    • Tuesday, December 14, 2021
      2021 Innovations in Regulatory Science Awards
      The fifth annual Innovations in Regulatory Science Awards presented by the Reagan-Udall Foundation for the FDA will be held Tuesday, December 14, 2021
      Read More
    • Friday, December 03, 2021
      Real-World Data Webinar Series: Data Standards
        Real-World Data Webinar Series: Data Standards for Drug and Biological Product Submissions Containing Real-World Data – Draft Guidance for Industry Friday, December 3, 2021
      Read More
    • Thursday, November 04, 2021
      A Public Webinar Series on FDA-Issued Guidance on Real-World Evidence
      A Public Webinar Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry   November 4, 2021 1:30-2:30 pm ET
      Read More
    • Monday, October 18, 2021
      A Practical Research Agenda for Treatment Development for Stimulant Use Disorder
      A virtual public workshop to discuss a practical research agenda toward treatment development for stimulant use disorder. 
      Read More
    • Tuesday, October 05, 2021
      Industry Voices—COVID-19 vaccine rollout shows real-world evidence was ready for the spotlight - Fierce Healthcare
      Just 10 months since administration of the first COVID-19 vaccine dose, hundreds of millions of people worldwide have been inoculated. As of mid-August, more than 4 billion vaccine doses have been administered worldwide, and over 50% of eligible…
      Read More
    • Tuesday, September 28, 2021
      FDA's Dr. Peter Marks, The COVID-19 Research Database, and Rep. Patrick Kennedy Recognized with Innovations in Regulatory Science Awards
      WASHINGTON, Sept. 28, 2021 /PRNewswire/ -- The Reagan-Udall Foundation for the FDA will present 2021 Innovations in Regulatory Science Awards to Peter Marks, MD, PhD, The COVID-19 Research Database, and former U.S. Representative Patrick J. Kennedy.
      Read More
    • Tuesday, September 28, 2021
      COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics
      COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics  
      Read More
    • Monday, September 27, 2021
      FDA’s Dr. Peter Marks, The COVID-19 Research Database, and Rep. Patrick Kennedy Recognized with Innovations in Regulatory Science Awards
      (September 27, 2021) The Reagan-Udall Foundation for the FDA will present 2021 Innovations in Regulatory Science Awards to Peter Marks, MD, PhD, The COVID-19 Research Database, and former U.S. Representative Patrick J. Kennedy.  
      Read More
    • Tuesday, September 14, 2021
      Clinical trials capacity should be considered strategic asset - BioCentury
      The U.S. government should consider creating a strategic national stockpile of capacity for clinical research. Government could also fund and help create a standing network of clinical trial sites that can immediately respond to future pandemics — and…
      Read More
    • Wednesday, September 08, 2021
      Virtual Public Workshop on COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics - Trial Site
      Sponsored by Reagan-Udall Foundation, key federal leadership and important stakeholders join a virtual public workshop on September 28 titled  “Federal COVID-19 Response: Clinical Evaluation of Therapeutics Lessons Learned.”  The event will disseminate…
      Read More
    • Tuesday, June 29, 2021
      Helping Patients Access Investigational Treatments - Cancer Commons
      Published on Cancer Commons, June 29, 2021, Curious Dr. George asks two leaders from the Reagan-Udall Foundation for the Food and Drug Administration (FDA) how their organization supports the FDA by striving to facilitate patient access to…
      Read More
    • Wednesday, June 23, 2021
      RDBA and FDA Foundation Partner to Provide Turnkey Resources to Retail Dietitians
      (July 23, 2021) Today, the Reagan-Udall Foundation for the FDA (FDA Foundation) and the Retail Dietitians Business Alliance (RDBA) jointly launched Supporting Healthier Eating in the New Normal: The Ultimate Retail Dietitians Toolkit. The toolkit…
      Read More
    • Tuesday, June 15, 2021
      Real-World Evidence Accelerator Facing Data Access Challenges For Vaccines - Scrip News for Pink Sheet
      The Reagan-Udall Foundation’s Evidence Accelerator program is navigating novel data flow challenges when it comes to assessing the safety and effectiveness of COVID-19 vaccines. The Evidence Accelerator was launched in April 2020 by Reagan-Udall, a…
      Read More
    • Thursday, June 03, 2021
      Reagan-Udall Foundation for the FDA Announces Two New Board Members
      (June 3, 2021) The Reagan-Udall Foundation for the Food and Drug Administration (FDA Foundation) is expanding its leadership with the addition of two new Board members: Christie Boutte, PharmD, RPh, Senior Vice President of Reimbursement, Innovation, and…
      Read More
    • Wednesday, June 02, 2021
      What Drives COVID Vaccine Hesitancy Among Moms? - MedPage Today
      Mothers are particularly hesitant about getting the COVID-19 vaccine for themselves and their children, according to the latest data.
      Read More
    • Wednesday, May 19, 2021
      US FDA Eyes New Investigational Drug Label Requirements That Bring International Harmonization - Pink Sheet
      The US Food and Drug Administration is considering new regulatory action to create more consistency in the labeling of investigational drugs to help reduce medication errors and protect patients as well as the integrity of the clinical trial results.…
      Read More
    • Tuesday, May 18, 2021 - Wednesday, May 19, 2021
      Potential Medication Error Risks With Investigational Drug Container Labels
      FDA and the Reagan-Udall Foundation for the FDA held a virtual public meeting on the potential medication error risks with investigational drug container labels. We solicited input from stakeholders (e.g., sponsors, investigators, clinical sites,…
      Read More
    • Friday, May 14, 2021
      FDA documents shed light on chaotic COVID decision-making during Trump administration - BioCentury
      Internal FDA and White House communications released by FDA in response to a Freedom of Information Act request provide a glimpse into the in-fighting, leaking and chaotic decision-making during some of the most fraught moments of the pandemic during the…
      Read More
    • Friday, May 14, 2021
      OSE's annual report details Sentinel efforts during COVID pandemic - Regulatory Focus
      The US Food and Drug Organization’s (FDA’s) Office of Surveillance and Epidemiology issued its first-ever annual report summing up the office’s work.   The scope of the office’s charge meant that during the pandemic, staff effort was largely directed…
      Read More
    • Wednesday, May 12, 2021
      2021 Annual Public Meeting
      On May 12, 2021, more than 100 stakeholders joined Reagan-Udall Foundation for the FDA Board of Directors for their Annual Public Meeting. The discussion centered on how public-private partnerships help advance the mission of FDA. Board members joined…
      Read More
    • Wednesday, May 12, 2021
      2021 Annual Public Meeting
      Each year, the Reagan-Udall Foundation for the FDA conducts an Annual Public Meeting of its Board of Directors to share its activities in support of the U.S. Food and Drug Administration. This free virtual meeting is open to the public, but advanced…
      Read More
    • Friday, April 16, 2021
      Listening to patients: The FDA goes from strength to strength - The Pharma Letter
      Hosted by the FDA’s Office of Patient Affairs (OPA), together with the National Organization for Rare Disorders (NORD) and the Reagan-Udall Foundation, Patient Listening Sessions are small and informal conversations that bring patients/caregivers and…
      Read More
    • Tuesday, March 23, 2021
      How to Talk to Patients Reluctant to Get a COVID-19 Vaccine - Medscape
      Family physician Mitchell A. Kaminski, MD, MBA, was still awash in feelings of joy and relief at recently being vaccinated against COVID-19 when a patient's comments stopped him cold. The patient, a middle-aged man with several comorbidities, had just…
      Read More
    • Tuesday, March 23, 2021
      'Part of recovery is awareness': Pandemic casts harsh spotlight on industry-wide lack of diversity in clinical trials -Endpoints
      Moderna emerged as an early leader in the race for a vaccine to stop Covid-19 in its tracks. The Cambridge, Massachusetts-based biotech bounded through development of one of the world’s first mRNA vaccines, but in September — when the pandemic was…
      Read More
    • Wednesday, March 17, 2021
      COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients
      The COVID-19 pandemic remains a significant global threat. However, despite urgent need, there remains uncertainty surrounding best practices for pharmaceutical interventions to treat COVID-19. In particular, conflicting evidence has emerged surrounding…
      Read More
    • Tuesday, March 16, 2021
      APhA Foundation names 2021 Jacob W. Miller Award recipient - Drug Store News
      Susan Winckler, CEO of the Reagan-Udall Foundation for the Food and Drug Administration, is the American Pharmacists Association Foundation’s 2021 recipient of the Jacob W. Miller Award. The award recognizes individuals who help to advance the Foundation…
      Read More
    • Tuesday, March 02, 2021
      Industry Voices—Harnessing a watershed moment for real-world data - Fierce Healthcare
      Across every facet of life, 2020 tested our resolve and resilience. COVID-19 stretched our systems to the breaking point, exposing inexcusable gaps and limitations in our systems. As a force of creative destruction and reinvention, however, it also…
      Read More
    • Monday, March 01, 2021
      Shot in the Arm: COVID-19 Boost to RWD - PharmaVOICE
      It’s early 2021 in the Northeast and a major snowstorm has just been announced. Schools will be closed for the next two days. Kids will be home and likely, quite happy to be off from school. Under normal circumstances, parents would be home too, trying…
      Read More
    • Monday, March 01, 2021
      COVID-19 Diagnostics Market Size Worth USD 8.04 Billion at 2.7% CAGR; Pharmaceutical Giants Such as Abbott and Roche to Pump More Funds for R&D Activities: Fortune Business Insights™ - Digital Journal
      The global COVID-19 diagnostics market size is projected to reach USD 8.04 billion by 2027, exhibiting a CAGR of 2.7% during the forecast period.
      Read More
    • Wednesday, January 20, 2021
      FDA Foundation Announces Research Funding Opportunity
      The Reagan-Udall Foundation for the FDA is pleased to announce the availability of funds to support studies of the real-world performance of two types of COVID-19 diagnostic tests. The purpose of this research is to evaluate real-world performance for…
      Read More
    • Tuesday, December 08, 2020
      2020 Innovations in Regulatory Science Awards Dinner
      Download the full event program
      Read More
    • Tuesday, October 13, 2020
      2020 Annual Public Meeting Highlights
       
      Read More
    • Saturday, April 11, 2020 - Saturday, April 11, 2020
      Real-World Evidence On COVID-19: US FDA Approaching With 'Sense Of Urgency'
      The COVID-19 pandemic is forcing the US Food and Drug Administration to step outside its comfort zone when it comes to using real-world evidence to inform rapid regulatory decision-making and clinical trial design. This experience could have a…
      Read More
    • Wednesday, December 11, 2019
      2019 Innovations in Regulatory Science Awards Dinner
      Join leaders in the regulatory field on December 11, 2019, to honor leaders and innovators making a significant impact on America's public health. 6 p.m. - 9 p.m. The Mayflower Hotel  1127 Connecticut Avenue NW Washington, DC 20036 Meet our 2019…
      Read More
    • Thursday, December 05, 2019 - Friday, December 06, 2019
      Repurposing Off-Patent Drugs: Research & Regulatory Challenges
      Join us for an interactive two-day workshop to discuss challenges around repurposing drugs that are already on the market but lack commercial and regulatory incentives for further research and development.
      Read More
    • Monday, June 24, 2019
      Visit us at DIA Global
      DIA 2019 Global Annual Meeting in San Diego
      Read More
    • Thursday, May 16, 2019
      Project Facilitate: Enhancing the Single Patient IND Process for Oncology
      May 16, 2019   |   1:00 PM to 3:30 PM FDA White Oak Campus Building 31, Room 1503 - Great Room 10903 New Hampshire Avenue, Silver Spring, MD 20993  
      Read More
    • Thursday, May 02, 2019
      2019 Annual Public Meeting Highlights
      Read More
    • Thursday, May 02, 2019
      2019 Annual Public Meeting
      Annual Public Meeting Set for May 2, 2019 Each year, the Foundation conducts an annual public meeting to discuss its activities and support of the U.S. Food and Drug Administration. The 2019 Annual Public Meeting will focus on pressing FDA initiatives…
      Read More
    • Monday, March 18, 2019
      Collecting Data from EA Treatment for Regulatory Submissions Presentation
      Executive Director June Wasser will present Collecting Data from EA Treatment for Regulatory Submissions at the Life Science Compassionate Access Summit at 4:00 pm, Monday, March 18th in Philadelphia. She will focus on:  Defining challenges and…
      Read More
    • Tuesday, December 04, 2018
      2018 Innovations in Regulatory Science Awards Dinner Highlights
      Read More
    • Tuesday, December 04, 2018
      2018 Innovations in Regulatory Science Awards Dinner
      The Reagan-Udall Foundation for the FDA honored two longtime U.S. Food and Drug Administration leaders and an independent public-private partnership as the 2018 recipients of the Innovations in Regulatory Science Awards. This year’s Innovations in…
      Read More
    • Monday, November 19, 2018
      Leveraging Real-World Treatment Experience from EA Protocols
      See Event Highlights and Download the Meeting Report  Monday, November 19, 2018   |  10:00 AM to 4:30 PM U.S. Food and Drug Administration White Oak Campus, Building 31, Great Room 10903 New Hampshire Avenue, Silver Spring, MD 20993 
      Read More
    • Monday, November 19, 2018
      Expanded Access Programs and Real-World Evidence: Public Meeting
      Expanded access programs, sometimes also called “compassionate use” programs, provide patients with serious or immediately life-threatening diseases or conditions access to investigational products outside of clinical trials
      Read More
    • Friday, May 04, 2018
      2018 Annual Public Meeting Highlights
      Collaboration and partnership, two key aspects of the Reagan-Udall Foundation for the FDA’s commitment to advancing regulatory science, were on full display when leaders from the FDA, the regulatory science community and the medical community gathered in…
      Read More
    • Tuesday, December 05, 2017
      2017 Innovations in Regulatory Science Awards
      Read More
    • Tuesday, April 04, 1922
      Call for Nominations: Reagan-Udall Foundation for the FDA Seeks Nominations for the Innovations in Regulatory Science Awards
      (April 4, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) seeks nominations for its annual Innovations in Regulatory Science Awards. These awards recognize outstanding contributions made by individuals or organizations in the field of…
      Read More
    • 2021 Innovations in Regulatory Science Awards Highlights
      Celebrating Excellence in Regulatory Science More than 200 regulatory science colleagues joined our fifth annual Innovations in Regulatory Science Awards, celebrating outstanding leadership, innovation, and advocacy that safeguards this nation's public…
      Read More
    • RDBA and FDA Foundation Partner to Provide Turnkey Resources to Retail Dietitians - The Associated Press
      Today, the Reagan-Udall Foundation for the FDA (FDA Foundation) and the Retail Dietitians Business Alliance (RDBA) jointly launched Supporting Healthier Eating in the New Normal: The Ultimate Retail Dietitians Toolkit.
      Read More
    • COVID-19 Vaccine Confidence Project - Journal of the American Pharmacists Association
      Published in the Journal of the American Pharmacists Association, June 11, 2021, Throughout much of 2020 and the beginning of 2021, while coronavirus disease 2019 (COVID-19) continued to grow and spread, government and public health officials worldwide
      Read More
    • Post-COVID-19 Syndrome: Leveraging the Patient Perspective and Technological Innovations to Enable the Delineation of Effective Treatments - The Journal Drugs
      More than 32 million individuals have survived a confirmed COVID-19 viral infection in the USA [1, 2], and a substantial proportion of post-COVID survivors are suffering from prolonged, recurrent, and/or newly emerging symptoms that span across bodily…
      Read More
    • FDA’s Vaccine Efforts Expand to Developing Public Confidence - American Medical Association
      Scientists at the Food and Drug Administration (FDA) have devoted countless hours to ensuring that the COVID-19 vaccines being deployed and those in the development pipeline are safe and effective. But it’s another task being done outside of the lab that…
      Read More
    • Industry Voices — COVID-19 vaccine development was a historic achievement. We'll need cutting-edge technology to make sure it ends the pandemic - Fierce Healthcare
      After nine months of suffering, isolation and economic downturn on an unprecedented international scale, the expedited development and approval of COVID-19 vaccines has shown us the light at the tunnel’s end. Having an end in sight is not the same as…
      Read More
    • What if we captured the spirit and urgency of Covid-19 research to cure cancer?
      In recent months, scientists and policymakers around the globe have rallied together with one common goal: to eliminate Covid-19. Budgets have been revised to funnel money toward research, competitive barriers between scientists and companies have been…
      Read More
    • Vaccine hesitancy part 2: Effective strategies for a human-centered health campaign - Atlantic Council
      Trust is health’s most valuable player COVID-19 has made clear that the politicization of health is incredibly dangerous; the health of billions of individuals is at stake, but so too is trust in pharmaceutical companies, in the scientific process, and …
      Read More
    • Leading Health Care and Infectious Disease Experts Join Together to Discuss COVID-19 Vaccine Safety, Equity and Distribution - Associated Press
      December 17, 2020 (Washington, D.C.) As Americans patiently await their turn for COVID-19 vaccination, a group of leading medical, health equity and public policy experts discussed and answered questions as part of a national briefing today about…
      Read More
    • US Agency Grants Approval of Pfizer's COVID Vaccine And Doses Are Expected in Days - Science Alert
      US regulators have authorised the first coronavirus vaccine for emergency use, marking an inflection point in the pandemic and kicking off what's set to be the largest vaccination campaign in US history.
      Read More
    • Countdown to a Coronavirus Vaccine - The New Yorker
      On a hot afternoon in August, Debbie Honeycutt walked into the crowded waiting room of the Medical Center for Clinical Research, an experimental-treatment facility tucked inside a squat office building in San Diego. She was volunteer number four hundred…
      Read More
    • Michael J. Fox Foundation for Parkinson's Research Honored with Advocacy/Policy Award from Reagan-Udall Foundation for the FDA - PR Newswire
      NEW YORK, Dec. 9, 2020 /PRNewswire/ -- The Michael J. Fox Foundation for Parkinson's Research (MJFF) has received the Advocacy/Policy Award from the Reagan-Udall Foundation for the Food and Drug Administration. MJFF is the second organization ever to…
      Read More
    • Surescripts Fireside Chat with Dr. Amy Abernethy, Principal Deputy Commissioner and Acting CIO, FDA
      Tom Skelton, CEO of Surescripts, recently spoke with Dr. Amy Abernethy of the FDA, about the impact of COVID-19 and the evolving data needs of public health.    
      Read More
    • FDA’s Amy Abernethy, Friends of Cancer Research, and The Michael J. Fox Foundation for Parkinson’s Research Honored with Innovations in Regulatory Science Awards
      Honorees to be recognized virtually on December 8, 2020
      Read More
    • We may soon have a COVID-19 vaccine. But will enough people take it? - Reuters
      ZURICH/LONDON (Reuters) - With COVID-19 vaccine trial results looking positive, governments and pharmaceutical firms face their next daunting challenge: convincing the world to get inoculated. Public resistance to vaccines has been much discussed this…
      Read More
    • In Brief - The Cancer Letter
      Reagan-Udall receives $250,000 from Rockefeller Foundation for COVID-19 Diagnostics Evidence Accelerator
      Read More
    • Officials clarify military role in coronavirus vaccination amid wariness - Roll Call
      President Donald Trump has often touted the role of the military in distributing a COVID-19 vaccine, but health officials close to the process who are concerned about public distrust are taking pains to say the federal government won’t actually be…
      Read More
    • Black Americans are the most hesitant to get a COVID-19 vaccine - USA Today
      Black Americans distrust the government so much they're not participating in large numbers in COVID-19 clinical trials, and many say they won't get a COVID-19 vaccine – at least not until many others get it. Although the first two large clinical trials…
      Read More
    • Reagan-Udall Foundation for the FDA Secures New Grant from The Rockefeller Foundation for COVID-19 Diagnostics Evidence Accelerator
      The Reagan-Udall Foundation for the FDA has received funding from The Rockefeller Foundation to support the COVID-19 Diagnostics Evidence Accelerator launched earlier this year in collaboration with Friends of Cancer Research. As a science-driven…
      Read More
    • Rushing COVID-19 Vaccination Could Undermine Overall Success, Vaccine Experts Warn FDA - IDSE
      Extraordinary and unusual measures may be needed to rapidly develop and distribute a vaccine against SARS-CoV-2, but those efforts should not compromise the safety and efficacy of any product that reaches the market, according to the FDA Vaccines and…
      Read More
    • ‘There’s only one chance to do this right’—FDA panel wrestles with COVID-19 vaccine issues - Science
      Concerns raised yesterday by an advisory group to the U.S. Food and Drug Administration (FDA) may once again tap the brakes on Operation Warp Speed, the U.S. government’s $10.8 billion push to rapidly move candidate COVID-19 vaccines from concept to…
      Read More
    • Patient Warehousing Emerges As Another COVID-19 Vaccine Confidence Problem - Pink Sheet
      Executive Summary CDC officials designing distribution plans worry some eligible for vaccination may wait for a better product to emerge. Federal officials are now confronting another challenge for the uptake of a potential coronavirus vaccine –…
      Read More
    • FDA advisory committee debates safety and efficacy standards for a coronavirus vaccine - The Washington Post
      Vaccine experts on Thursday rigorously debated the Food and Drug Administration’s planned standards for clearing a coronavirus vaccine quickly for broad use, discussing what level of evidence would be sufficient to establish safety and effectiveness.
      Read More
    • Researchers Find Doubts About COVID-19 Vaccine Among People Of Color - NPR
      The Food and Drug Administration is preparing for the eventual rollout of one or more COVID-19 vaccines — by identifying the concerns that some people have about taking such a vaccine. At a meeting Thursday of experts advising the FDA on COVID-19…
      Read More
    • Facing vaccine doubts, US grapples with building confidence in coronavirus shots - BioPharma Dive
      Dive Brief: The Centers for Disease Control and Prevention does not back mandates that healthcare workers or other essential employees receive COVID-19 vaccines, with a CDC official stating Thursday the agency would prefer instead to "build trust and…
      Read More
    • US faces major hurdles for COVID-19 vaccine distribution: Vaccine advisory committee - MSN
      Any coronavirus vaccine that could be authorized for emergency use by the U.S. Food and Drug Administration (FDA) faces several additional hurdles after completing the final stage of clinical trials. That was the theme of key issues addressed today by…
      Read More
    • FDA Panel Stresses Safety, Diversity, Efficacy for COVID-19 Vax - MedPage Today
      COVID-19 vaccine safety, dueling efficacy standards, and representation of groups from racial and ethnic minorities to children drew focus Thursday at arguably the most watched FDA advisory committee meeting ever.
      Read More
    • CDC distribution roadmap, safety oversight plans, and other takeaways from FDA’s big COVID-19 vaccine meeting - ExBulletin
      In less than a year, scientists around the world have rallied against COVID-19 and developed promising vaccines that could stem the pandemic. Concerns remain, however, and, against this backdrop, senior government experts took over Thursday to discuss…
      Read More
    • Group Of Independent Experts To Advise FDA On Coronavirus Vaccine Approval - WUWM Milwaukee
      It's up to the Food and Drug Administration to decide whether a COVID-19 vaccine is safe and effective enough for public distribution. Today, the agency convened a group of independent experts to offer advice on the way forward. NPR science correspondent…
      Read More
    • In historic Covid-19 adcomm, vaccine experts debate a sea of questions — but offer no clear answers - Endpoints News
      The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers. Read more
      Read More
    • Confidence still lacking in future COVID-19 vaccines - BioWorld
      With the lack of public trust and confidence the biggest barrier to SARS-CoV-2 vaccines in the U.S., the risk of granting an emergency use authorization (EUA) to a vaccine with safety issues or questionable efficacy could destroy confidence in future FDA…
      Read More
    • Core Concept: The pandemic is prompting widespread use—and misuse—of real-world data - PNAS
      COVID-19 has swept across the world, overwhelming healthcare systems and raising countless questions about how best to diagnose patients, treat infections, save lives, and contain the pandemic. In short order, researchers have launched randomized trials…
      Read More
    • FDA study finds fear and distrust among front-line workers and minority groups around COVID-19 vaccines - Fierce Pharma
      Powerful, illuminating and sobering—that’s the description from a research group summing up its initial listening sessions with front-line workers and minority groups about a vaccine. Tasked with tapping key audiences to learn their questions and…
      Read More
    • What to expect from the official COVID-19 vaccine committee - ABC News
      As the race for an effective COVID-19 vaccine continues, the public will get inside look at one a crucial part of the Food and Drug Administration's decision-making process: the first meeting of its normally obscure advisory committee. Never before has…
      Read More
    • October, no surprise: COVID-19 vax AdComm booked for the 22nd - RAPS
      The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee plans to meet on 22 October to discuss matters related to authorization and licensure of vaccines for COVID-19. No application will be on the docket at…
      Read More
    • FDA Applauds Role of Clinical Trials in Fighting COVID-19 - The Association of Clinical Research Professionals
      “Clinical trials are critical” in the battle against the global COVID-19 pandemic, Amy Abernathy, principal deputy commissioner and acting CIO of the U.S. Food and Drug Administration (FDA), told attendees of the Veeva R&D and Quality Summit on…
      Read More
    • Remarks by Dr. Hahn to the Global Coalition for Regulatory Science Research
      I’m delighted to be with you today for this important meeting of the Global Coalition for Regulatory Science Research.  I only wish that we could be together in person. I want to thank Bill Slikker and his co-chair of the Scientific Program Committee,…
      Read More
    • Expanded access eRequest app allows physicians to submit EA requests online - The Cancer Letter
      The Reagan-Udall Foundation for the FDA, with input from experts at FDA, has introduced an Expanded Access eRequest app to streamline expanded access for individual patients in non-emergency settings. “Time is critical when patients have a serious or…
      Read More
    • Ask the Accelerators: Dr. William Morice of Mayo Clinic Laboratories on RWE and COVID-19 diagnostics - Aetion
      Ask the Accelerators is a series highlighting the perspectives and work of organizations and individuals participating in the COVID-19 Evidence Accelerator. Organized by the Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) and…
      Read More
    • It Just Got Easier for Physicians to Help Their Patients Gain Access to Investigational Treatments
      When a patient is in need of an important medicine, paperwork and forms are the last thing their physician wants to deal with. In some cases, it’s necessary, but the U.S. Food and Drug Administration is doing everything we can to keep it to a minimum.…
      Read More
    • New Expanded Access eRequest App Allows Physicians to Submit EA Requests Online
      Submitting expanded access requests to FDA just got easier for physicians. The Reagan-Udall Foundation for the FDA, with input from experts at FDA, today launched Expanded Access eRequest to streamline expanded access for individual patients in non-…
      Read More
    • Covid-19 Molecular Diagnostic Testing — Lessons Learned - The New England Journal of Medicine
      On February 4, 2020, the U.S. secretary of health and human services declared that emergency use of diagnostics for SARS-CoV-2 was justified, triggering emergency authority for the Food and Drug Administration (FDA) to grant an emergency use…
      Read More
    • Ask the Accelerators: Dr. Nirosha Lederer on COVID-19’s implications for the future of RWE, and what we’ve learned so far - Aetion
      Ask the Accelerators is a series highlighting the perspectives and work of organizations and individuals participating in the COVID-19 Evidence Accelerator. Organized by the Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) and…
      Read More
    • UPDATED: Aetion pushes Series B to $82M as pandemic puts real-world evidence under the spotlight - Endpoints News
      Former FDA chief Scott Gottlieb’s favorite real-world evidence platform is getting a new stream of cash, as it nears what will likely be the biggest test of the young company so far. Aetion, the New York health tech startup, has for the second time…
      Read More
    • FDA In Brief: Findings from Real-World Data Study Reveal Higher Risk of Hospitalization and Death Among Cancer Patients with COVID-19, Underscore Health Disparities
      The following quote is attributed to Harpreet Singh, M.D., Associate Director, Cancer in Older Adults and Special Populations, FDA’s Oncology Center of Excellence; and Director, Division of Oncology 2, FDA’s Center for Drug Evaluation and Research:
      Read More
    • FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability
      The U. S. Food and Drug Administration has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed development and to quickly authorize tests that the science…
      Read More
    • Industry Voices—How real-world EHR data are enhancing our understanding of COVID-19 - Fierce Healthcare
      Traditionally, the healthcare industry has moved slowly when embracing new technology innovations. However, over the past few months, it has been forced to rapidly advance to confront the challenges posed by COVID-19. One area that has received…
      Read More
    • FDA to Participate in Covid-19 Diagnostics Evidence Accelerator - Bloomberg Law
      The FDA will participate in the Covid-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research. Read more
      Read More
    • HAHN PLEDGES TO EVALUATE FUTURE OF DIAGNOSTICS REGULATION - POLITICO Prescription Pulse
      At a Medical Device Innovation Consortium fireside chat Thursday, FDA Commissioner Stephen Hahn said the agency will take a fresh look at how it regulates diagnostics and digital technologies after the coronavirus pandemic. The FDA will be working to…
      Read More
    • Pandemic pushes FDA to 'accelerate' real-world evidence efforts, Hahn says - MedTech Dive
      FDA is upping efforts to incorporate real-world data in evaluation of COVID-19 diagnostics and antibody tests, announcing Thursday participation in a partnership exploring how to use that data to improve testing quality, better inform population testing…
      Read More
    • FDA joins Reagan-Udall, Friends of Cancer Research to form COVID-19 Diagnostics Evidence Accelerator - The Cancer Letter
      FDA is participating in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics.  The accelerator is organized by the Reagan-Udall Foundation for FDA in collaboration with Friends…
      Read More
    • Accelerating the fight against COVID-19 with real-world data on tests - BioCentury
      Almost every aspect of the fight against COVID-19 depends on the ability to determine whether an individual is or has been infected with SARS-CoV-2, but more than six months into the pandemic there is still uncertainty about the accuracy of widely used…
      Read More
    • To expedite progress against COVID-19, a public-private “accelerator” taps into real-world data - The Cancer Letter
      This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.
      Read More
    • FDA joins new, public-private COVID-19 diagnostic research accelerator effort - FierceBiotech
      The FDA has joined a public-private diagnostic research project with the goal of bringing more real-world data to bear against the novel coronavirus, and gauging the accuracy of different kinds of tests. Formed by the Reagan-Udall Foundation and Friends…
      Read More
    • New accelerator to boost real-world COVID-19 diagnostics - Regulatory Focus
      A collaboration to use real-world diagnostics evidence will seek to answer key questions about the novel coronavirus, including epidemiologic patterns, individual risk factors, and characteristics of immunity that might develop after infection with COVID…
      Read More
    • New COVID-19 Diagnostics Evidence Accelerator Applies Real-World Data to Answer Urgent Questions on SARS-CoV-2 Testing
      Today, the Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research, announced the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder, collaborative project to leverage real-world data in the diagnostic test (e.g…
      Read More
    • US FDA Looking To Real-World Evidence To Fill in Gaps On COVID-19 Vaccines - Pinksheet
      Principal Deputy Commissioner Amy Abernethy suggests FDA may clear a COVID-19 vaccine on smaller than usual clinical datasets and rely on real-world data to fill in the gaps. Abernethy said a new public-private partnership is starting to explore how it…
      Read More
    • The pivotal role of real-world data in a pandemic - Biocentury
      Real-world data is taking on a critical role in the age of COVID-19 drug development, where hasty authorizations are being made on limited datasets and natural history data is being collected in real time. Teams across the industry have stepped up to…
      Read More
    • A New Trend in Drug Development: Leveraging Data from Expanded Access - Cancer Therapy Advisor
      A manuscript detailing this study is under revision and awaiting acceptance by the British Journal of Clinical Pharmacology.  The study was funded using an unrestricted grant from myTomorrows, a global company that connects patients to expanded access…
      Read More
    • WHEN YOU DON’T QUALIFY FOR A CLINICAL TRIAL: EXPANDED ACCESS MIGHT HELP - Triage Cancer
      When dealing with a cancer diagnosis, often times the best form of treatment can be offered through a clinical trial. We de-bunked common myths in this blog post, talking about the benefits of considering clinical trials, in efforts to shift the…
      Read More
    • Real-World Data Partnership On COVID-19: US FDA Drawn To Consistency, Diversity of Aetion's Datasets - Pinksheet
      FDA's Amy Abernethy tells the Pink Sheet that initial priorities are likely to include studying COVID-19 natural history and how patients are faring under various medication regimens. Aetion's ability to perform consistent analyses across a variety of…
      Read More
    • Coronavirus (COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response
      Today, we are announcing another step in our effort to harness diverse streams of data to understand and respond to COVID-19. The U.S. Food and Drug Administration has entered into an agreement with Aetion to collaborate on advanced analytical techniques…
      Read More
    • FDA Teams Up With Data Company Aetion to Study Virus Progression - Bloomberg Law
      The FDA said Tuesday it’s pairing up with the data company Aetion to research Covid-19 complications and what types of medicines virus patients are taking, which could help researchers learn more about which treatments are effective.
      Read More
    • FDA, partnering with New York health tech firm, seeks to collect ‘real-world’ data on Covid-19 - STAT
      The Food and Drug Administration said Tuesday that it will launch a new research project focused on real-world evidence — data collected by insurance companies, in electronic health records, and in other places in medicine — to learn more about Covid-19…
      Read More
    • A New, Better Normal in Health Care? - National Review
      The COVID-19 crisis has fast-tracked long-contemplated, patient-centric changes in medicine.
      Read More
    • BioCentury This Week: Special Edition - Getting Real about COVID-19 Data
      Amy Abernethy, FDA’s principal deputy commissioner and acting CIO, and Mark McClellan, director of the Duke-Margolis Center for Health Policy at Duke University, described in podcast interviews with BioCentury’s Washington Editor Steve Usdin how the…
      Read More
    • Health, Defense Agencies Should Cooperate to Beat COVID-19 - RealClearHealth
      The U.S. has been trying to contain COVID-19 through testing and social distancing. Now it’s time to kill it. What’s needed is intragovernmental cooperation, something that, sadly, is rare in the nation’s capital. In this case, Congress and the Trump…
      Read More
    • Beyond the Magic Bullet: Medical Progress Is Often Incremental - National Review
      Life won’t completely return to normal while the novel coronavirus remains a threat to health and to life. More than 60,000 Americans have already lost their lives to this virus; while older people seem especially vulnerable, the virus has demonstrated…
      Read More
    • Accelerating the collection of real-world data about COVID-19 - Biocentury
      The Reagan-Udall Foundation and Friends of Cancer Research are trying to put real-world data to use against COVID-19. If there are silver linings to the COVID-19 crisis, one is the way groups and individuals who often have adversarial or competitive…
      Read More
    • Politico Prescription Pulse
      Document Drawer The Reagan-Udall Foundation for the FDA and Friends of Cancer Research launched the COVID-19 Evidence Accelerator, a public-private partnership to use data analytics to understand the virus.
      Read More
    • Real-World Evidence On COVID-19: US FDA Approaching With 'Sense Of Urgency' - Pink Sheet
      "Identifying key questions and core data elements is at the heart of a new initiative launched by the Reagan-Udall Foundation and Friends of Cancer Research. The COVID-19 Evidence Accelerator provides a venue for major data organizations, government and…
      Read More
    • First Look at Gilead Drug Virus Response to Open Data Floodgates - Bloomberg Law
      "A new initiative called the COVID-19 Evidence Accelerator aims to pool ongoing data sources from government and academic researchers, health systems, and private companies to solutions for C
      Read More
    • COVID-19 Evidence Accelerator Leverages Real-World Evidence in FDA’s Response to Global Pandemic
      The Reagan-Udall Foundation for the FDA (Foundation) in collaboration with Friends of Cancer Research (Friends) today announced the COVID-19 Evidence Accelerator, an expansive public-private partnership combining the efforts of academic, government, and…
      Read More
    • One-Stop Resource Helps Patients and Healthcare Providers Link to COVID-19 Clinical Trials and Expanded Access Programs
      To help patients, caregivers, physicians, and other healthcare providers find COVID-19 treatment resources as quickly and easily as possible, the Reagan-Udall Foundation for the FDA today launched the online COVID-19 Treatment Hub.
      Read More
    • Reagan-Udall Foundation for the FDA Names Susan Winckler as CEO
      The Reagan-Udall Foundation for the Food and Drug Administration has named Susan C. Winckler, RPh, Esq., former FDA Chief of Staff, as its Chief Executive Officer. She will assume the role on May 1, 2020.
      Read More
    • Food Industry Leader Molly Fogarty Named to Board of Directors
      Molly Fogarty, Senior Vice President of Nestlé in the U.S., has been appointed to the Board of Directors for the Reagan-Udall Foundation for the Food and Drug Administration.
      Read More
    • Nominations now closed
      Read More
    • 2019 Innovations in Regulatory Science Awards Dinner Highlights
      Read More
    • Winners of 2019 Innovations in Regulatory Science Awards Announced
      FDA’s Theresa Mullin, Compassionate Use Advisory Committee, and Cystic Fibrosis Foundation to be Honored with Innovations in Regulatory Science Awards  Honorees to be recognized on December 11 in Washington, DC Washington, DC - The Reagan-Udall…
      Read More
    • Duke's Hernandez Appointed to Reagan-Udall Foundation Board of Directors
      The Reagan-Udall Foundation for the Food and Drug Administration has named Dr. Adrian F. Hernandez to its Board of Directors.
      Read More
    • Reagan-Udall Foundation for the FDA invites Nominations for IMEDS Steering Committee
      The Reagan-Udall Foundation for the FDA seeks nominations for key positions on its Steering Committee. Comprised of 12 members, the IMEDS Steering Committee provides oversight and guidance on the operation of IMEDS by advising on strategic direction,…
      Read More
    • FDA Eases Access to Unapproved Cancer Drugs - OBR Daily
      "Patients with cancer are treated with drugs already approved by the U.S. Food and Drug Administration (FDA) or with an investigational agent in a clinical trial. But there are some patients who may need access to investigational drugs outside the realm…
      Read More
    • Project Facilitate: FDA’s Plan to Ease Expanded Access to Novel Therapies - The ASCO Post
      The U.S. Food and Drug Administration (FDA) plans to provide oncologists with greater help in acquiring expanded access to investigational therapies. Deemed Project Facilitate, the pilot program was announced at a press briefing during the 2019 ASCO…
      Read More
    • FDA Launches Expanded Access Pilot ‘Project Facilitate’ - Regulatory Focus
      The US Food and Drug Administration (FDA) on Monday launched a new pilot program, dubbed Project Facilitate, aimed at helping physicians complete expanded access requests for cancer patients.  
      Read More
    • FDA, Reagan-Udall launch end-to-end expanded access program for cancer - BioCentury
      FDA's Oncology Center of Excellence and the Reagan-Udall Foundation launched Expanded Access Navigator and Project Facilitate, two separate but coordinated pilot programs to provide patients and physicians with expanded access to oncology drugs. The…
      Read More
    • Enhancements to EA Navigator Improve Patient Access to Investigational Therapies
      Embargoed until 9 a.m. EDT June 3, 2019 Media Inquiries: Lea Ann Browning-McNee, 301-509-1846 Consumer/Provider Inquiries: 202-849-2075   Expanded Access Navigator Improves Patient Access to Investigational Therapies New enhancements make it easier…
      Read More
    • Sharpless Calls for a Nimble, Flexible, More Efficient US FDA - Pinksheet
      "Sharpless said FDA's organization also must ensure collaboration across disciplines and locations, as well as with outside groups. In a speech to the Reagan-Udall Foundation annual meeting later in the day, though, he acknowledged that outside…
      Read More
    • Sharpless Begins to Learn the Ropes While FDA Center Directors Look to the Future
      Read Zach Brennan’s reference to the Foundation's Annual Public Meeting in his Regulatory Focus™ article:  “Sharpless Begins to Learn the Ropes While FDA Center Directors Look to the Future”
      Read More
    • Wasser Departs Reagan-Udall Foundation for the FDA
      June Wasser Departs Reagan-Udall Foundation for the FDA Amar Bhat, PhD, named Interim Executive Director
      Read More
    • Call for Nominations: Innovations in Regulatory Science Awards
      Reagan-Udall Foundation for the Food and Drug Administration is seeking nominations through June 14, 2019, for its third annual Innovations in Regulatory Science Awards. These Awards honor outstanding achievements of individuals and organizations that…
      Read More
    • Report on Leveraging Real-World Treatment Experience from Expanded Access Protocols
      Learn about strategies for Leveraging Real-World Treatment Experience from Expanded Access Protocols in the report from our November public meeting at the FDA White Oak Campus. We brought all the stakeholders together --- patient advocates, physicians,…
      Read More
    • Updated FDA Guidance on Expanded Access
      The FDA updated its guidance to clarify that listing in our Expanded Access Navigator Company Directory satisfies the 21st Century Cures Act requirement of making EA policies readily available. Read "How should we post our expanded access policy?" for…
      Read More
    • CDER 2018 Drug Safety Priorities Report
      New Drug Safety Priorities Report for 2018 highlights CDER’s safety work with a reference to our IMEDS program that "allows public and private entities access to the Sentinel System.”  
      Read More
    • FDA to facilitate access to unapproved drugs
      Biocentury coverage on the FDA’s expanded access program and collaboration with the Reagan-Udall Foundation is available here: https://www.biocentury.com/biocentury/regulation/2018-12-14/how-fda-plans-help-patients-get-expanded-access-unapproved-drugs
      Read More
    • The FDA Sentinel Initiative: An evolving National Resource
      Read The FDA Sentinel Initiative—An Evolving National Resource pubished in New England Journal of Medicine in November 2018 by Platt et al featuring our IMEDS program. 
      Read More
    • Coming soon for Expanded Access Policies
      Updates are coming to expanded access procedures and data use. Read the latest from FDA Law Blog featuring key messages from our public meeting on leveraging expanded acccess data.
      Read More
    • Expanded Access Data Can Support Approval Decisions, US FDA Says
      Pink Sheet featured an article authored by Kate Rawson which highlights important takeaways from our public meeting, Leveraging Real-World Treatment Experience from Expanded Access Protocols on November 19, 2018 at the FDA White Oak Campus. Find the…
      Read More
    • Reagan-Udall Foundation for the FDA Announces Appointment of Three New Board Members
      The Reagan-Udall Foundation for the Food and Drug Administration expands its leadership with the appointment of three new Board members: Andrew C. von Eschenbach, M.D., former FDA Commissioner; Edward John Allera JD, pharmacist and attorney with…
      Read More
    • Winners of 2018 Innovations in Regulatory Science Awards Announced
      We're excited to honor two longtime U.S. Food and Drug Administration leaders and an independent public-private partnership as the 2018 recipients of the Innovations in Regulatory Science Awards to be honored on December 4, 2018.
      Read More
    • Wasser Joins Hands On Classrooms Advisory Panel
      Our Executive Director June S. Wasser has agreed to serve on the advisory panel for a new initiative of the Grocery Manufacturers Association Science and Education Foundation (GMA SEF). In this capacity Wasser will be an external reviewer of the next…
      Read More
    • Real-World Evidence to Increase Value in Health Care
      Mark McClellan and his colleagues at Duke-Margolis Health Policy Center outline how real-world evidence can increase value in health care in this Growth Commentary referencing Reagan-Udall Foundation for the FDA’s IMEDS program.
      Read More
    • Reagan-Udall Foundation at the 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE)
      During the ICPE conference, our Executive Director, June Wasser, will be discussing the importance of the Foundation’s IMEDS (Innovation in Medical Evidence Development and Surveillance) program, which provides a framework and entry point for private-…
      Read More
    • Call for Nominations to Honor Regulatory Science Leaders
      The Reagan-Udall Foundation for the Food and Drug Administration is pleased to announce the call for nominations for the 2018 Innovations in Regulatory Science Awards. The Foundation will be honoring the leadership and achievements of those whose work…
      Read More
    • FDA Commissioner Previews OND Changes at Annual Meeting
      Dr. Scott Gottlieb indicated that the upcoming changes to the FDA Office of New Drugs would likely be in place this summer, when taking questions at the Foundation's Annual Public Meeting in this article from RAPS.
      Read More
    • IMEDS Panel Presentation at DIA Global Annual Meeting 2018
      Stop by booth #622 to learn more about the Foundation and our programs including, Innovation in Medical Evidence Development and Surveillance (IMEDS), the Expanded Access Navigator, and our Fellowship initiative.
      Read More
    • Pre-approval Access Webinar
      The Reagan-Udall Foundation for the FDA's Executive Director, June Wasser, was a presenter on a June 6th webinar sponsored by Johnson & Johnson and NYU Langone Health. She explained how patients use the Foundation's Expanded Access Navigator. The…
      Read More
    • Panel of Commissioners Discuss Evolution of FDA at Foundation's Public Meeting May 4th
      Each year the Foundation conducts an annual meeting, open to the public, to discuss its activities and how it supports FDA. This year's meeting takes place May 4th, from 10 a.m until noon, at the law offices of Alston and Bird (950 F St. NW, Washington,…
      Read More
    • 2018 Annual Public Meeting
      We have reached room capacity so registration to attend the meeting is now closed. We look forward to seeing those who registered before April 19th and thank everyone for your support of the Reagan-Udall Foundation for the FDA. The public is still …
      Read More
    • Press release on Expanded Access Navigator after "right-to-try" vote
      DATELINE: WASHINGTON D.C. - MARCH 22, 2018 Right-To-Try law not a shortcut to investigational drugs – Expanded Access Navigator can reduce confusion. Serious or terminally ill patients hoping House passage of federal Right-To-Try legislation will…
      Read More
    • Navigator presentation at CBI's Expanded Access Programs 2018
      Executive Director June Wasser's talk on the Evolving Scope of the Expanded Access Navigator starts at 11am, Wednesday March 28th and includes an update on its expansion into rare diseases. This year's Expanded Access Programs focus is "Design…
      Read More
    • Rare Disease Day at NIH
      Stop by the foundation's table at NIH's Rare Disease Day on March 1st for a demonstration of the Expanded Access Navigator. It's a website that focused initially on oncology but is adding resources for the rare disease community in 2018.
      Read More
    • FDA News Picks Up on Foundation Fellowships as Workforce Multiplier
      FDA hopes to bolster its scientific staff in 2018 and this piece in FDA News explains how the Reagan-Udall Foundation's upcoming Fellowship program could funnel talented post-docs into the agency it was created to support. 
      Read More
    • Sentinel workshop and next-day training
      New analytic tools and methods enhancements have unlocked access to more diverse sources of data than ever before, improving the quality of evidence for safety surveillance. That’s why each year FDA and key leaders from across the Sentinel System…
      Read More
    • Senator Enzi's Gala Remarks Reach Back to Foundation's Start
      Senator Mike Enzi's remarks reminded attendees that Congress named the Reagan-Udall Foundation for the FDA after two leaders fighting neurodegenerative disorders.
      Read More
    • Press release announcing winners of Innovations in Regulatory Science Awards
      The secret's out, and we're excited to honor the two leaders who will be receiving the inaugural Innovations in Regulatory Science Awards at the Gala December 5th. Here's the press release we shared with media and sponsors.
      Read More
    • Mission and Programs Presentation
      Curious about public-private partnerships and the Reagan-Udall Foundation for the FDA? Happy to schedule a presentation on our history, vision, mission and opportunities.
      Read More
    • Save the Date for 2017 Gala
      Inaugural Reagan-Udall Foundation for the FDA Innovations in Regulatory Science Awards Gala  Image
      Read More
    • FDA Commissioner announces Navigator expansion to Rare Diseases
      In one powerful blog post, Dr. Gottlieb waives requirements to wait for a full convening of IRBs to approve single patient expanded access treatments, announces the future expansion of the Foundation's Navigator to rare diseases and offers clarity on…
      Read More
    • Keynote Address at Indiana Life Sciences Summit
      Find our how the Foundation got its start and where it's headed at the Indiana Life Sciences Summit in Indianapolis. Executive Director June Wasser presents a keynote address on the Foundation's mission and public-private partnerships on Tuesday, 10/10. 
      Read More
    • Innovation Awards Nomination Forms
      Nominations are now being accepted for the Innovations in Regulatory Science Awards. These awards will be presented at the inaugural Innovations in Regulatory Science Awards Gala on December 5th, 2017 at the Kaiser Permanente Center for Total Health in…
      Read More
    • The Expanded Access Navigator to be Featured at Philadelphia's Pre-Approval Access Conference
      Executive Director June Wasser leads a 1:45pm session Tuesday, 9/26 on how the Navigator started and resources it shares with patients and physicians.
      Read More
    • Fox News Tampa's Dr. Jo Calls Navigator an Exciting Advancement
      Dr. Joette Giovinco shared the launch of the Expanded Access Navigator in a Fox Medical Team TV and online report. She credited the FDA and advocacy groups who provided input for the online tool and the clip shows how companies are listing single patient…
      Read More
    • Learn About IMEDS at ICPE in Montreal
      The Foundation welcomes questions and discussion about IMEDS at the 33rd International Conference on Pharmacoepidemiology and Therapeutic Risk Management Aug 26-30. Stop by Booth 45 for a personal discussion of IMEDS capabilities.
      Read More
    • Press Release Launching Expanded Access Navigator
      Dateline: Washington, D.C. The Reagan-Udall Foundation for the FDA launches Navigator website to share resources and policies on expanded access to investigational therapies.
      Read More
    • Forbes article explains how the Navigator helps doctors request expanded access
      Saving time is critical for physicians treating seriously ill patients who have exhausted alternatives to expanded access. So Forbes contributor Alison Bateman-House explains how the Navigator spells out timelines in this piece called "How To Try An…
      Read More
    • STAT features Navigator article by Exec. Dir. June Wasser
      In the article, Wasser explains why the FDA asked its foundation to create a public-private partnership launching the Navigator. Legislation like the 21st Century Cures Act and changes in regulation require drug companies to make any expanded access…
      Read More
    • MedPage Today describes the Navigator's 8 steps for expanded access
      This short MedPage article focuses on the Navigator's step-by-step guided experience for patients and physicians: from identifying treatment and exploring clinical trials to seeking IRB approval and treatment/reporting requirements.
      Read More
    • DIA Global Forum article traces roots of IMEDS
      Executive Director June Wasser explains the evolution of IMEDS, the Foundation's public-private, big-data partnership modeled after FDA's Sentinal program.
      Read More
    • Denver Post notes Navigator as an FDA improvement in article about Right-To-Try
      The Post and other publications picked up CQ-Roll Call's Andrew Siddons' analysis of the potential impact of federal Right-To-Try legislation. Read the article here: the Reagan-Udall Foundation and Navigator are part of the concluding paragraphs about…
      Read More
    • FDA Blog kicks off industry coverage of Navigator launch
      Read More
    • Susan G. Komen calls Navigator a lifeline
      In this article, Interim President and CEO Ellen Willmot shares her hope that the Navigator will make it easier for breast cancer physicians and patients to apply for, and benefit from, expanded access to investigational treatments
      Read More
    • Navigator's Oncology Focus Cited by ASCO
      The American Society of Clinical Oncology helped develop the Navigator and in this post describes it as a clearinghouse for the single-patient expanded access policies of dozens on leading biopharmaceutical companies. 
      Read More
    • The Health Care Blog Shares Uses for Navigator
      This post points out that the Navigator will expand from an oncology focus to other therapeutic areas in the future, and walks through a hypothetical Zika case where clear expanded access information would be critical.
      Read More
    • Pharmaceutical Commerce links Gottlieb to Navigator's aims
      This magazine article says the Navigator streamlines information-gathering and links the launch to FDA Commissioner Scott Gottlieb's statements that the expanded access process should be less expensive and time-consuming.
      Read More
    • Biotech-Now Urges Companies to Use Navigator Directory
      This blog from the Biotechnology Innovation Organization reminds companies they can comply with the 21st Century Cures Act’s requirements to make their expanded access policy publicly available by listing it on the Expanded Access Navigator's Company…
      Read More
    • Infodocket Credits Team Effort for Navigator
      Quoting the FDA Voice Blog, this online post mentions the Navigator's public-private partners who help guide patients and physicians through the expanded access process.
      Read More

    Subscribe for updates from the Reagan-Udall Foundation for the FDA

    Subscribe
    (202) 849 - 2075
    1333 New Hampshire Ave, NW
    Suite 420
    Washington, DC 20036
    admin@reaganudall.org
    • facebook
    • twitter
    • linkedin
    • youtube

    © Reagan-Udall Foundation for the FDA
    © Reagan-Udall Foundation for the FDA