Animal & Veterinary

Animals with Intentional Genomic Alterations

Picture of goats, a chicken, a cow, and pigs


On January 19, 2017, the FDA released for public comment draft revised Guidance for Industry (GFI) #187, “Regulation of Intentionally Altered Genomic DNA in Animals.” This draft revised guidance expands the scope of the existing GFI #187 to address animals with intentionally altered genomic DNA developed through use of genome editing technologies, as well as techniques such as rDNA in genetic engineering.

Draft Revised Guidance #187: Regulation of Animals with Intentionally Altered Genomic DNA

Final Guidance #187 Released 1/15/2009

Draft Guidance Released 9/18/2008


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Page Last Updated: 09/21/2018
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