Monday, January 19, 2009

FDA Final Guidance On Genetically Engineered Animals

The procedure of genetic engineering uses recombinant DNA for introducing new characteristics or traits into an animal. The new guidance, Guidance for Industry #187 - Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs, provides all the needed details, so that the producers of these animals will know what to do in order to get the FDA's approval. Moreover, producers of these animals will also have to follow the law and regulations of the National Environmental Policy Act. I think these are truly remarkable times in the life of scientific discovery. Do you find these advances astounding or troubling? 



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