🐾FDA Guidance on Type VII Veterinary Master Files for R&D Released
Type VII Veterinary Master File for Research and Development and Risk Reviews; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #260 entitled "Type VII Veterinary Master File for Research and Development and Risk Reviews." This draft guidance, when finalized, will describe FDA's current thinking regarding the use of Type VII Veterinary Master Files (Type VII VMFs).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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The draft guidance outlines regulations for Type VII Veterinary Master Files related to the research and development of animal products, impacting compliance and operational processes for businesses in veterinary medicine and biotechnology sectors. Companies must engage with FDA early in product development, ensuring adherence to new regulatory standards.