Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Master Protocols for Drug and Biological Product Development." This draft guidance revises and replaces the previous draft guidance for industry of the same name issued on December 22, 2023. The draft guidance provides recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on submissions to support regulatory review. The primary focus is on randomized trials utilizing a master protocol that are intended to contribute to a demonstration of safety and substantial evidence of effectiveness. The considerations in this guidance apply to a range of therapeutic areas. The draft guidance is intended to clarify the Agency's thinking on the use of master protocols in drug and biological product development.

Abstract as published in the Federal Register.

The comment window is still open until August 24, 2026. This is the point where industry shapes the final rule — submit comments through the Federal Register document below.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.