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. Read "How should we post our expanded access policy?" for detail.
The Reagan-Udall Foundation for the FDA (FDA Foundation) is an independent 501(c)(3) created by Congress to advance regulatory science to help the U.S. Food and Drug Administration accomplish its mission. The FDA Foundation works to improve health and safety through stakeholder engagement and public-private partnerships that facilitate innovation, foster the use of real-world evidence, and identify modern tools and policies to keep pace with today’s rapidly evolving science.
Lea Ann Browning-McNee
301-509-1846 (cell)
Lmcnee@reaganudall.org
Mary McNamara
202-276-7822 (cell)
mmcnamara@reaganudall.org