Animals with Intentionally Altered Genomic DNA
On January 18, 2017, the FDA released draft revised Guidance for Industry (GFI) #187, “Regulation of Intentionally Altered Genomic DNA in Animals,” and requested public comment regarding the regulation of animals with intentionally altered genomic DNA, including animals produced through the use of genome editing technologies or genetic engineering. 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
FDA Issues Final Guidance on Regulating Genetically Engineered Animals [ARCHIVED]CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals (PDF - 200KB)FDA's Response to Public Comments [ARCHIVED]Creating Human Drugs From Genetically Engineered Animals January 15, 2009 Transcript for FDA’s Media Briefing on FDA's Release of a Final Guidance for Industry on the Regulation of Genetically-Engineered Animals (PDF - 100KB) [ARCHIVED]Notice: Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable recombinant DNA Constructs
Draft Guidance Information
Released 9/18/2008
DRAFT - CVM GFI #187 Regulation of GE Animals Containing Heritable rDNA Constructs (PDF - 196KB) [ARCHIVED]Regulation of Genetically Engineered Animals September 18, 2008 Transcript of Media Briefing on FDA’s Draft Guidance for Industry on the Regulation of Genetically Engineered Animals (PDF - 79KB)September 18, 2008 Audio of Transcript of Media Briefing on FDA’s Draft Guidance for Industry on the Regulation of Genetically Engineered Animals (MP3 - 272KB)
Approvals
AquAdvantage Salmon FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients Environmental Assessment - NADA 141-453 (PDF - 763KB)FONSI - NADA 141-453 (PDF - 664KB)FDA Approves Orphan Drug ATryn to Treat Rare Clotting Disorder [ARCHIVED]NADA 141-294 Bc6 rDNA construct in GTC 155-92 Goats - original approval (PDF - 213KB)Environmental Assessment for the Bc6 rDNA Construct in GTC 155-92 Goats (PDF - 131KB)Finding of No Significant Impact for the Bc6 rDNA Construct in GTC 155-92 Goats (PDF - 29KB)Federal Register Final Rule