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CENTER FOR DRUG EVALUATION AND RESEARCH
Accelerating Rare disease Cures (ARC) Program Update
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Call for Proposals: Rare Disease Endpoint Advancement Pilot Program
FDA’s Rare Disease Endpoint Advancement (RDEA) Pilot Program is accepting proposals for this quarter until June 30, 2026.
The RDEA Pilot Program supports novel efficacy endpoint development for drugs that treat rare diseases. Sponsors whose RDEA proposals are admitted into the pilot program have the opportunity for additional interaction with interdisciplinary FDA experts and the associated review divisions on endpoint development.
Meeting requests may be submitted on a rolling basis and must be received by the last calendar day of each quarter. See submission deadlines below.
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RDEA Pilot Program Quarterly Proposal Submission Deadlines
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March 31
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June 30
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Sept. 30
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Dec. 31
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For more information about the program and to submit a proposal, please visit the Rare Disease Endpoint Advancement Pilot Program webpage. Visit CDER’s ARC webpage for an overview and information about the ARC Program.
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