Type VII Veterinary Master File for Research and Development and Risk Reviews

Issue Date: August 17, 2026
Issued by: Center for Veterinary Medicine
Topic(s): Biotechnology, Cellular & Gene Therapy
Status: Final

Type VII Veterinary Master File for Research and Development and Risk Reviews

This guidance describes FDA’s current thinking on the use of Type VII Veterinary Master Files (Type VII VMFs), which are appropriate for the research and development of animal cells, tissues, and cell- and tissue-based products, gene therapies, and heritable intentional genomic alterations in animals.

Download the Guidance Document

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