FDA launches pilot program to speed early-phase drug trials
read at raps ↗RegulatoryPositive
The U.S. Food and Drug Administration announced a new pilot program aimed at accelerating the review of Phase 1 clinical trials for investigational new drugs.
The initiative introduces a rolling submission process, letting sponsors submit data incrementally instead of waiting for a complete package.
Sponsors will be paired with qualified research institutions to help streamline the expedited review, the agency said.
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This writeup was produced by pharmadog from original reporting by raps.
Original headline: “FDA to test new approach to expediting Phase 1 trials”
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