Past Events

Wasser Departs Reagan-Udall Foundation for the FDA
June Wasser Departs Reagan-Udall Foundation for the FDA Amar Bhat, PhD, named Interim Executive Director
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.
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.
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.
CDER 2018 Drug Safety Priorities Report
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:
The FDA Sentinel Initiative: An evolving National Resource
Read The FDA Sentinel Initiative—An Evolving National Resource pubished in New Engl
Coming soon for Expanded Access Policies
Updates are coming to expanded access procedures and data use.
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
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.