Issue Date: January 7, 2025
Issued by: Center for Veterinary Medicine
Topic(s): Biotechnology, Cellular & Gene Therapy, Animal Cell-Based Products
Status: Draft
CVM GFI #260 – Type VII Veterinary Master File for Research and Development and Risk Reviews
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.
Download the Guidance Document
