Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Master Protocols for Drug and Biological Product Development." This draft guidance revises and replaces the previous draft guidance for industry of the same name issued on December 22, 2023. The draft guidance provides recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on submissions to support regulatory revi