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# Drug Development Master Protocol Guidance
- URL: https://www.fdaweb.com/drug-development-master-protocol-guidance/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:19:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156025

FDA has published a draft guidance, *Master Protocols for Drug and Biological Product Development*, with recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on submitting documentation to support regulatory review. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/master-protocols-drug-and-biological-product-development?ref=fdaweb.com) says its primary focus is on randomized umbrella and platform trials that are intended to contribute to a demonstration of safety and substantial evidence of the effectiveness of a drug.

“The concepts discussed may also be useful to consider for early-phase or exploratory umbrella and platform trials as well as those conducted to satisfy post-marketing commitments or requirements,” FDA says. “The recommendations and considerations in this guidance do not apply to master protocols evaluating first-in-human drugs given the unique attributes from both a trial design and regulatory perspective that must be considered.”

The guidance includes an Introduction; Background; Considerations on Design and Analysis; Considerations on Trial Oversight, Data Sharing, and Dissemination of Information; References; and an Appendix.