CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

Accelerating Rare disease Cures (ARC) Program Update

CDER Driving Scientific and Regulatory Progress in Rare Disease Drug Development

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 September 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 will have the opportunity for additional interaction with interdisciplinary FDA experts on endpoint development as well as the associated review divisions.

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.  

For more information about the program and to submit a proposal, please visit Rare Disease Endpoint Advancement Pilot Program's webpage.Visit CDER’s ARC webpage for an overview and information about the ARC Program.

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