Page 49 - Breeding Edge ebook
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If FDA “were to regulate animals with intentionally altered genomic DNA as a new drug, the regulation
would be disproportionate to the risk and not based in science. In fact, it would regulate the identical
animal differently depending on whether the altered genomic DNA occurred naturally or by genomic
editing," Simplot wrote.
"The consequence that follows is that it will become nearly impossible to effectively use promising and
emerging technologies in animal genetics.”
At this point, it’s not clear where FDA will end up. It did not say when it will release its final guidance.
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