Rare Disease Refresh: FDA’s Rare Disease Framework Initiative October 14, 2026 By James E. Valentine & Charles G. Raver & Frank J. Sasinowski —

https://www.thefdalawblog.com/2026/10/rare-disease-refresh-fdas-rare-disease-framework-initiative/?utm_source=rss&utm_medium=rss&utm_campaign=rare-disease-refresh-fdas-rare-disease-framework-initiative FDA’s new Rare Disease Framework Initiative is a thoughtful, ambitious, and laudable effort to build a regulatory structure that systematically supports rare disease therapeutic development and review. Detailed in the October 2026 white paper, A New Framework for Rare Disease Review, the initiative is led by the Rare Disease Innovation Hub in partnership with the Office of the Commissioner, CDER, and CBER, with engagement from CDRH and other relevant offices.