FDA unveils new rare disease pilot program to increase agency-sponsor communications

The FDA on Fri­day un­veiled new de­tails around a rare dis­ease pi­lot pro­gram that seeks to in­crease rapid, ad-hoc com­mu­ni­ca­tions be­tween six spon­sors work­ing on such treat­ments and the agency.

Be­tween Jan. 2, 2024 and March 1, 2024, pi­lot pro­gram par­tic­i­pants will be se­lect­ed based on ap­pli­ca­tion readi­ness (e.g., spon­sors who can move their de­vel­op­ment pro­grams for­ward more quick­ly), with up to three par­tic­i­pants for each cen­ter.

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