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FDA GUIDANCE · DRAFTJanuary 7, 2025

CVM GFI #251 - Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status
Draft
Topic
Biotechnology, Cellular & Gene Therapy, Premarket, Animal Cell-Based Products
Issue date
January 7, 2025

This is a draft guidance — issued for comment and not for implementation. It signals FDA’s current thinking and the direction of a requirement, but the final document may change. Track the comment window on the FDA page.

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