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

We also received similar feedback through several meetings in which FDA participated, including a two-day public meeting with the Reagan-Udall Foundation for the FDA in May 2023 and two listening sessions led by the Substance Abuse and Mental Health…
In May 2023, the Reagan-Udall Foundation hosted a 2-day public meeting with FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA), entitled “Considerations for Buprenorphine Initiation and Maintenance Care.”
Earlier this year, Ultragenyx reached agreement with the Agency that CSF HS can be used as a surrogate endpoint for accelerated approval based on the body of data presented by the company, along with a consortium of academics and other industry sponsors…