Friday, January 16, 2009

FDA's Final Guidance on GE animals

The Food and Drug Administration (FDA) has issued final guidance on its approach to regulating genetically engineered (GE) animals. The guidance is aimed at industry, but consumers may also be interested in FDA regulation of GE animals. (FDA regulates GE animals under the "new animal drug" provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), and FDA must approve them before they are allowed on the market.) FDA has also produced a consumer oriented document on its regulation of GE animals.

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