WASHINGTON, June 24 -- Food and Drug Administration has issued a notice called: Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on June 24 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Master Protocols for Drug and Biological Product Development." This draft guidance revises and replaces the previous draft guidance for industry of the same name issued on December 22, 2023. The draft guidance provides recommendations on the design and analysis of trials conduct...