CVM GFI #57 Preparation and Submission of Veterinary Master Files

Issue Date: January 1, 1995
Issued by: Center for Veterinary Medicine
Topic(s): Chemistry, Manufacturing, and Controls (CMC)
Status: Final

CVM GFI #57 Preparation and Submission of Veterinary Master Files

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.

Download the Guidance Document

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