- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary Medicine
This document is intended to provide guidance for the preparation and submission of master files to the Center for Veterinary Medicine. This document discusses the types of master files, information needed, submission format, procedures governing the review of master files, and obligations of the master file holder.
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:
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-2021-D-0617.