Announcements

(October 11, 2024) Steven A. Grossman, JD; Jeff Shuren, MD, JD; and the Real-World Evidence Collaborative will receive the Reagan-Udall Foundation for the FDA’s 2024 Innovations in Regulatory Science Awards on December 10. The prestigious awards…
(WASHINGTON, July 26, 2024) – The Reagan-Udall Foundation for the FDA (the Foundation) launched a new tool for leaders in health care delivery—the RAISE Action Framework.
(WASHINGTON, April 17, 2024) –The ASH Research Collaborative (ASH RC) and the Reagan-Udall Foundation for the Food and Drug Administration (FDA Foundation) are launching the Real-World Evidence Consortium for Sickle Cell Disease (SCD) to develop…

Coverage

The reorganization had its origins in the Reagan-Udall Foundation report, which was released less than two years ago. The report focused on ways to clarify the mission of the human food program and achieve more urgency in preventing foodborne illnesses.
The oncology quality, characterization, and assessment of real-world data (Oncology QCARD) Initiative was formed to develop a set of minimum study design and data elements needed to evaluate the fitness of the real-world data (RWD) source(s) proposed in…
The rare disease policy calendar in Washington has been packed. Highlights have included an advisory committee meeting for a Barth syndrome treatment from Stealth BioTherapeutics, a meeting about FDA’s Rare Disease Innovation Hub convened by the Reagan-…