May 4, 2017: The Reagan-Udall Foundation for the Food and Drug Administration (FDA) will hold its annual public meeting on May 4th, 10:00-11:45am at the offices of Alston & Bird LLP, 950 F Street, NW, Washington, DC. Acting FDA Commissioner Stephen Ostroff will provide opening remarks. Read the full press release here.
Reagan-Udall in the News
Sentinel Offers Drug Firms “Unique” Venue for Post-Market Studies, Pfizer Says
February 5, 2017 – Pink Sheet
Pfizer representative attended the 2017 Sentinel Workshop to describe the IMEDS pilot experience and the unique advantages to participating in the collaboration. He also discussed a number of possible applications for the modular programs that have been developed for Sentinel [Read the full article here].
FDA Touts EvGen, IMEDS Program Ensures Patient Safety
January 19, 2017 – Med Device Online
The Medical Evidence Development and Surveillance System (IMEDS) supports the FDA’s vision of leveraging FDA’s Sentinel system to become a national resource, allowing entities outside of the FDA to conduct research for advancing patient safety. Researchers across the U.S. can now access IMEDS’ modular programs, as well as customized epidemiologic studies, to investigate safety issues. [Read the full article here]
Introducing IMEDS, a Public-Private Resource for Evidence Generation
January 17, 2017 – FDA Voice
FDA Commissioner Dr. Robert Califf writes about the value of Innovation in Medical Evidence Development and Surveillance (IMEDS) in supporting FDA’s mission in post-market product safety evidence generation. [Read the full article here]
FDA’s Nonprofit Arm Plots Out New Compassionate Use Navigator
April 7, 2016 – Regulatory Affairs Professionals Society (RAPS)
Patients and physicians desperate for access to a potentially life-saving investigational drug will be able to take some solace in the fact that the US Food and Drug Administration’s (FDA) nonprofit, known as the Reagan-Udall Foundation, is currently working on an online tool to help aid the process of obtaining what are known as “compassionate use” or “expanded access” treatments. [Read the full article here]