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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