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Published online 19 September 2008 | Nature | doi:10.1038/news.2008.1120
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FDA to regulate genetically engineered animals
Drug agency opens door to market approval for transgenic animals.
After ten years of anticipation and back-room wrangling, on 18 September the US Food and Drug Administration (FDA) published a document outlining how it proposes to regulate genetically engineered animals. The proposed regulations effectively treat such animals as drugs in order to provide grounds for FDA regulation.
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I am glad that FDA will treat genetically engineered animals as drugs in order to provide grounds for FDA regulation. Since transgenic animals may have environmental impacts, pose risks to animal or human health, or seem to raise safety questions the producers have not addressed, it is logic to regulate them as "new animal drugs". Now, the oncogene-containing iPS cells have been created in various places and even integrated into viable animals and passed over generations, should FDA take a look of these potentially very harmful "regenerative" medicine? Shi V. Liu (SVL@logibio.com; http://im1.biz; http://blog.sina.com.cn/im1)