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Animals with Intentional Genomic Alterations

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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


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