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raps·Sep 15·1 min read
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FDA launches pilot program to speed early-phase drug trials

Sep 15, 2026·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.

source

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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