Master protocols guidance published
FDA issued guidance on the design, analysis, and regulatory submission of clinical trials conducted under master protocols.
What this means
The FDA issued new rules for "master protocols," which let researchers test multiple drugs or diseases in one clinical trial framework to speed up development. Today's guidance explains how companies should design these complex trials and what data to submit for review. These clearer standards could help get treatments to patients faster by streamlining trials for diseases like cancer or rare conditions where testing individual drugs separately isn't practical.
From the source
Docket Number: FDA-2023-D-5259
Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research
Additional Guidance Resources
• Master Protocols: Guidance Snapshot
• Master Protocols: Guidance Recap Podcast
• Master Protocols: Podcast Transcript
This guidance document provides recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on the submission of documentation to support regulatory review.
Submit Comments
Submit Comments Online
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2023-D-5259.
Reproduced from FDA Drugs (Whats New) · view original · public domain or open-licensed government work