GUIDANCE DOCUMENT
Cross-Center Master Files: Where to Submit Draft Guidance for Industry November 2025
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
Submit Comments by
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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
- Docket Number:
- FDA-2025-D-5715
- Issued by:
-
Guidance Issuing OfficeOffice of the Commissioner, Office of the Chief Medical Officer, Office of Combination ProductsCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Drug Evaluation and ResearchCenter 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The draft guidance provides recommendations to master file holders, regarding where (i.e., to which FDA center) to submit a master file that is referenced in and intended to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).
Questions?
- Combination Products Guidance Contact
- Office of Combination Products
- combination@fda.gov
- 301-796-8930
- 301-847-8619