FDA Revises Draft Guidance on Master Protocols for Drug, Biologic Trials
June 27, 2026
June 27, 2026
WASHINGTON, June 27 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a revised draft guidance outlining recommendations for the design, analysis and regulatory review of clinical trials conducted under master protocols, aiming to support the development of drugs and biological products across a range of therapeutic areas.
The notice, published in the Federal Register, gives stakeholders until Aug. 24, 2026, to submit comments before . . .
The notice, published in the Federal Register, gives stakeholders until Aug. 24, 2026, to submit comments before . . .
