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CVM Uses Seven-Step Process to Evaluate Safety, Effectiveness of GE Animals
FDA Approves First Human Biologic Produced by GE Animals
FDA Approves First GE Animal, Human Health Product
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FDA Approves Orphan Drug ATryn
Federal Register Final Rule
NADA 141-294 Bc6 rDNA construct in GTC 155-92 Goats - original approval (PDF - 86KB)
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)
Draft Guidance Info
Regulation of Genetically Engineered Animals
CVM GFI #187 Regulation of GE Animals Containing Heritable rDNA Constructs (PDF - 239KB)
September 18, 2008 Transcript of Media Briefing on FDA’s Draft Guidance for Industry on the Regulation of Genetically Engineered Animals (PDF - 79KB)
September 18, 2008 Audio of Transcript of Media Briefing on FDA’s Draft Guidance for Industry on the Regulation of Genetically Engineered Animals (MP3 - 272KB)
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