BRIEF—FDA publishes revised Draft Guidance Master Protocols

The US Food and Drug Administration (FDA) has  issued a revised draft guidance for industry titled, “Master Protocols for Drug and Biological Product Development,” along with an accompanying guidance snapshot and recap podcast episode.

This revised draft guidance reflects the FDA’s consideration of public comments on the previous draft guidance for industry of the same name issued on December 21, 2023, including the addition of guidance on basket trials, a type of master protocol where a drug is evaluated for multiple diseases, conditions, or disease subtypes.