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GUIDANCE DOCUMENT

CVM GFI #260 - Type VII Veterinary Master File for Research and Development and Risk Reviews January 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-5376
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

A Type VII Veterinary Master File (VMF) is a file that can receive submissions to FDA’s Center for Veterinary Medicine (CVM) that may contain confidential data and information related to unique regulatory considerations such as research and development of animal cells, tissues, and cell- and tissue-based products (ACTPs), intentional genomic alterations (IGAs) in animals, gene therapy, or a risk review for an ACTP or IGA in an animal, where the information submitted is generally not intended to support product approval.  

The use of a Type VII VMF is appropriate for research and development of ACTPs, gene therapies, and IGAs in animals, and for risk review of ACTPs and IGAs in animals because, for these types of novel products and rapidly evolving technologies, there may be unique regulatory considerations, concerning different types of issues, that may call for a developer’s interactions with CVM at an earlier stage than would normally take place with traditional products that CVM regulates.  As described in the guidance, developers should open a Type VII VMF to cover these interactions with CVM.  The scope of this guidance is limited to the use of Type VII VMFs for research and development and risk review requests.  There are other uses of Type VII VMFs, but they are not addressed in this guidance.

The benefits of a Type VII VMF include:  (1) confidential exchange of information with FDA that is not subject to user fees, (2) an opportunity for increased communication with FDA during early stages of product development, and (3) a process for reporting research studies outside of an investigational file.

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-2024-D-5376.

Questions?

Contact Point
Lynne Boxer
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
Lynne.Boxer@fda.hhs.gov
240-402-0611
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