In January 2025, FDA released the final guidance CVM GFI#187B on the approval process for animals containing heritable intentional genomic alterations. Check out the Final guidance document here #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process . This compliments the final CVM#187A that describes FDA’s risk-based approach to determining their requirements and recommendations to animals containing heritable intentional genomic alterations that was issued in May 2024. You can read that guidance document and the associated Federal Register Notice by following this link. CVM GFI #187A Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach | FDA
