🐾FDA Reopens Comment Period for Type VII Veterinary Master File Guidance
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice announcing the availability of a draft guidance for industry (GFI) that appeared in the Federal Register of January 7, 2025. In that notice, FDA requested comments on draft GFI #260 entitled "Type VII Veterinary Master File for Research and Development and Risk Reviews." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments before the agency begins work on the final version of the guidance.
Learn More🐾FDA Guidance on Type VII Veterinary Master Files for R&D Released
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #260 entitled "Type VII Veterinary Master File for Research and Development and Risk Reviews." This draft guidance, when finalized, will describe FDA's current thinking regarding the use of Type VII Veterinary Master Files (Type VII VMFs).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.
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