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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.