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FDA Unveils Final Rules On Engineered Animals

Law360 (January 15, 2009, 12:00 AM EST) -- Federal regulators have issued final guidelines on the review process for drugs and food that come from genetically engineered animals.

The U.S. Food and Drug Administration on Thursday laid out its recommendations for how producers of genetically engineered animals can gain approval for their applications for new drugs and food. The agency said the guidance also clarifies its statutory and regulatory authority, highlighting what officials need to look for when evaluating new applications.

Under the animal drug provisions of the federal Food, Drug and Cosmetic Act,...
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