Animals with Intentional Genomic Alterations
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
- Draft Revised Guidance #187: Regulation of Intentionally Altered Genomic DNA in Animals
- Q&A on FDA Regulation of Intentional Genomic Alterations in Animals
Final Guidance #187 Released 1/15/2009
- CVM GFI #187 - Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs
We have published a Draft Revised Guidance #187, “Regulation of Intentionally Altered Genomic DNA in Animals” (see above). - FDA’s Response to Public Comments on Draft Guidance for Industry #187, Released 9/18/2008
- Notice: Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable recombinant DNA Constructs
Approvals
- FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses
- FOI Summary for NADA 141-542 (pPL657 rDNA Construct in Domestic Pigs)
- GalSafe® Pigs Environmental Assessment
- Finding of No Significant Impact for NADA 141-542 (pPL657 rDNA Construct in Domestic Pigs)
- FDA Approves Additional Treatment for Adults and Adolescents with Hemophilia A or B and Inhibitors
- FOI Summary – NADA 141-511 Bc2371 rDNA construct in R69 New Zealand white rabbits
- AquAdvantage Salmon
- FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients
- FOI Summary - NADA 141-453
- FDA Approves Orphan Drug ATryn to Treat Rare Clotting Disorder
- FOI Summary for NADA 141-294 Bc6 rDNA construct in GTC 155-92 Goats - original approval
Information for Industry
- Industry Q&A
- FDA CVM Animal Biotechnology Webinar for Developers
- CVM Public Webinar: Genome Editing in Animals
Consumer Information
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