FDA Issues Draft Guidance On Engineered Animals

Law360, New York (September 18, 2008, 12:00 AM EDT) -- In an effort to clarify its regulatory authority in the development of genetically engineered animals, the U.S. Food and Drug Administration has released draft guidance regarding how these animals and the products made from them should reach the market.

Released Thursday, the document focuses on new animal drug provisions of the Federal Food Drug and Cosmetic Act that are designed to enhance the safety requirements for producers of GE animals and products derived from GE animals. The FDA has allotted a 60-day period for comment on...
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