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Home » FDA Kicks Off Pilot to Help Develop Novel Endpoints for Rare Disease Trials
FDA Kicks Off Pilot to Help Develop Novel Endpoints for Rare Disease Trials
As part of its commitments under the newly reauthorized Prescription Drug User Fee Act (PDUFA VII), the FDA has launched the Rare Disease Endpoint Advancement (RDEA) pilot that will test a new meeting system to help sponsors of rare disease clinical trials develop efficacy endpoints.