Tuesday - June 30, 2026
FDA Revises Draft Guidance on Master Protocols for Drug, Biologic Trials
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June 27 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a revised draft guidance outlining recommendations for the design, analysis and regulatory review of clinical trials conducted under master protocols, aiming to support the development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 . . .

Targeted News Service Document Request Form

This document is available to you by e-mail if you complete the form below with relevant information. There may be a fee for this article or ongoing service of similar materials. We will be in touch shortly.

Click here for more information about our products