Genetically Engineered Animals
Introduction
Genetic engineering is a targeted and powerful method of introducing desirable traits into animals using recombinant DNA (rDNA) technology. DNA is the chemical inside the nucleus of a cell that carries the genetic instructions for making living organisms.
In January, 2009, the Food and Drug Administration issued a final guidance for industry on the regulation of genetically engineered (GE) animals. The guidance explains the process by which FDA is regulating GE animals and provides a set of recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law. While the guidance is intended for industry, FDA believes it may also help the public gain a better understanding of this important and developing area.
What is FDA Doing?
Final Guidance Released 1/15/2009
FDA Issues Final Guidance on Regulating Genetically Engineered Animals [ARCHIVED]CVM GFI #187 Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (PDF - 134KB)General Q&A 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Draft Guidance Information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196KB) [ARCHIVED]Regulation of Genetically Engineered Animals September 18, 2008 Transcript of Media Briefing on FDA’s Draft Guidance for Industry on the Regulation of Genetically Engineered Animals (PDF - 79KB)September 18, 2008 Audio of Transcript of Media Briefing on FDA’s Draft Guidance for Industry on the Regulation of Genetically Engineered Animals (MP3 - 272KB)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