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 (the Foundation) is an independent 501(c)(3) created by Congress to advance the mission of the FDA to modernize product development, accelerate innovation, and enhance product safety. The Foundation works to advance regulatory science, support development and dissemination of reliable information, and facilitate engagement and information exchange.
Lea Ann Browning-McNee
301-509-1846 (cell)
Lmcnee@reaganudall.org
