2023-28210: Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Master Protocols for Drug and Biological Product Development." The draft guidance addresses the design and analysis of trials conducted under a master protocol as well as the submission of documentation to support regulatory review. The primary focus is on randomized umbrella and platform trials 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 The draft guidance is intended to clarify the Agency's thinking on the use of master protocols in drug and biological product development, which was previously addressed in FDA's guidance entitled "COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention." FDA is also announcing the withdrawal of the guidance entitled "COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention."
The agency’s own summary, as published.
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