Events

The US Food and Drug Administration (FDA) on Monday launched a new pilot program, dubbed Project Facilitate, aimed at helping physicians complete expanded access requests for cancer patients.  

FDA's Oncology Center of Excellence and the Reagan-Udall Foundation launched Expanded Access Navigator and Project Facilitate, two separate but coordinated pilot programs to provide patients and physicians with expanded ac

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 said FDA's organization also must ensure collaboration across disciplines and locations, as well as with outside groups.

Read Zach Brennan’s reference to the Foundation's Annual Public Meeting in his Regulatory Focus™ article:

June Wasser Departs Reagan-Udall Foundation for the FDA Amar Bhat, PhD, named Interim Executive Director

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.

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.

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.