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Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Master Protocols for Drug and Biological Product Development." This draft guidance revises and replaces the previous draft guidance for industry of the same name issued on December 22, 2023. The draft guidance provides recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on submissions to support regulatory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 The draft guidance is intended to clarify the Agency's thinking on the use of master protocols in drug and biological product development.
- Document type
- Notice
- Federal Register document number
- 2026-12620
- Published
- Jun 24, 2026
- Action
- Notice of availability.
- Docket
- FDA-2023-D-5259
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on the draft guidance by August 24, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Topics (auto-tagged)
- Other FDA topics
Source: Federal Register API, document 2026-12620. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.