The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #260 entitled "Type VII Veterinary Master File for Research and Development and Risk Reviews." This guidance describes FDA's current thinking regarding the use of Type VII Veterinary Master Files (Type VII VMFs). Type VII VMFs are appropriate for research and development of animal cells, tissues, and cell- and tissue-based products (ACTPs), gene therapies, and heritable intentional genomic alterations (IGAs) in animals.
US Federal Register - FDA Guidance Notices · August 17, 2026
Type VII Veterinary Master File for Research and Development and Risk Reviews; Guidance for Industry
Original title: Type VII Veterinary Master File for Research and Development and Risk Reviews; Guidance for Industry; Availability
FDA guidance on Type VII Veterinary Master Files for research and development of animal cells, tissues, cell- and tissue-based products, gene therapies, and heritable genomic alterations in animals.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.