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GE at CVM
GE Plants
GE Animals
Background
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On September 18, 2008, FDA’s Center for Veterinary Medicine released draft Guidance for Industry #187 to clarify the Agency’s regulation of Genetically Engineered (GE) Animals.

The draft Guidance, along with several FAQ articles, is listed below. We encourage all interested parties to read these documents before providing public comment.

Public comments on this draft Guidance will be accepted until November 18, 2008. To comment, go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2008-D-0394.  (You can also go to http://www.regulations.gov/ and reference Docket FDA-2008-D-0394.)

FDA Press Release - FDA Issues Draft Guidance on Regulating Genetically Engineered Animals

Draft Guidance for Industry #187 - Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs | html | pdf |

Consumers Q&A

Industry Q&A

General Q&A

Fact Sheet

Consumer Article

Genetically Engineered Animals Graphic

Transcript for Media Briefing on FDA’s Draft Guidance for Industry on the Regulation of Genetically Engineered Animals

• September 18, 2008 [pdf 79KB] Audio [276 KB MP3]

U.S. Department of Agriculture's Animal and Plant Health Inspection Service

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