FDA Finalizes Guidance on Use of Type VII Veterinary Master Files for Research and Development and Risk Review

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US Food and Drug Administration

FDA Finalizes Guidance on Use of Type VII Veterinary Master Files for Research and Development and Risk Review

August 14, 2026

Today, the FDA finalized Guidance for Industry #260, which provides information regarding the use of Type VII Veterinary Master Files (VMF) for research and development and risk review. Type VII VMFs are appropriate for research and development of animal cells, tissues, and cell- and tissue-based products, gene therapies, and heritable intentional genomic alterations in animals.

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