Cross-Center Master Files: Where to Submit Draft Guidance for Industry November 2025

GUIDANCE DOCUMENT

• Docket Number: FDA-2025-D-5715
• Issued by: Office of the Commissioner, Office of the Chief Medical Officer, Office of Combination Products; Center for Biologics Evaluation and Research; Center for Devices and Radiological Health; Center for Drug Evaluation and Research; Center for Veterinary Medicine

The draft guidance provides recommendations to master file holders, regarding where (i.e., to which FDA center) to submit a master file that is referenced in and intended to support more than one regulatory submission for which the lead center may vary or where the information may need to be reviewed by more than one center to support review of the referencing submission(s).  The recommendations apply to master files submitted to the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and certain types of master files submitted to the Center for Veterinary Medicine (CVM).

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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-2025-D-5715.

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