The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Master Protocols for Drug and Biological Product Development." This draft guidance revises and replaces the previous draft guidance for industry of the same name issued on December 22, 2023. The draft guidance provides recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on submissions to support regulatory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 The draft guidance is intended to clarify the Agency's thinking on the use of master protocols in drug and biological product development.
US Federal Register - FDA Guidance Notices · June 24, 2026
Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry
Original title: Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability
FDA revises draft guidance on design, analysis and regulatory submission of master protocol trials for drugs and biologics.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.