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
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FDA’s Response to Public Comments on Draft Guidance for Industry #187, Released 9/18/2008 Creating Human Drugs From Genetically Engineered Animals January 15, 2009 Transcript for FDA’s Media Briefing on FDA's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Draft Guidance Information
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196KB) [ARCHIVED] Regulation of Genetically Engineered Animals September 18, 2008 Transcript of Media Briefing on FDA’s Draft Guidance for Industry on the Regulation of Genetically Engineered Animals(PDF - 79KB) September 18, 2008 Audio of Transcript of Media Briefing on FDA’s Draft Guidance for Industry on the Regulation of Genetically Engineered Animals(MP3 - 272KB)
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