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GUIDANCE DOCUMENT

CVM GFI #57 Preparation and Submission of Veterinary Master Files January 1995

Download the Final Guidance Document
Final
Docket Number:
FDA-2021-D-0617
Issued by:
Guidance Issuing Office
Center 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.

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-2021-D-0617.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002
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