Past Events

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

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.

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:

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