FDA GUIDANCE · FINALJanuary 7, 2025

CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process

What this record is not

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

Final

Topic

Premarket, Biotechnology, Investigational New Animal Drug (INAD), New Animal Drug Application (NADA)

Issue date

January 7, 2025

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