FDA Issues Draft Guides on Regulating Genetically Engineered Animals

Public comment on guidelines encouraged.

The Food and Drug Administration on Thursday released "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs", a draft of a guide on regulation of genetically engineered animals.

"Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment, and the production of new materials, and the FDA has long been involved in their scientific evaluation," said Randall Lutter, Ph.D., deputy commissioner for policy. "Our guidance provides a framework for both GE animals and products made from them to reach the market."

FDA is asking for public comments on the draft. The deadline to submit comments is Nov. 18, 2008. To view the 25-page document, click HERE.

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