WASHINGTON — A final guidance for industry on the regulation of genetically engineered animals was issued Jan. 15 by the U.S. Food and Drug Administration under the new animal drug provisions of the Federal Food, Drug and Cosmetic Act. Titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," the guidance clarifies FDA's statutory and regulatory authority and provides recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law.

"Genetic engineering is a cutting-edge technology that holds substantial promise for improving the health and well being of people as well as animals," said Randall Lutter, Ph.D., deputy commissioner for policy. "In this document, the agency has articulated a scientifically robust interpretation of statutory requirements. This guidance will help the FDA efficiently review applications for products from GE animals to ensure their safety and efficacy."

Last September, FDA released the draft guidance with a 60-day public comment period and received about 28,000 comments. The agency has summarized and responded to these comments.

Meanwhile, the FDA's Center for Veterinary Medicine has been working with developers of GE animals on both early stage and more mature applications. "At this time, it is our intent to hold public scientific advisory committee meetings prior to making decisions on GE animal-related applications" said Bernadette Dunham, D.V.M., Ph.D., director of CVM.

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