The agency is seeking public comment and is meant to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.
The comment period for the draft guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," runs for 60 days and closes Nov. 18. The 25-page document is available online at http://www.fda.gov/cvm/GEAnimals.htm.
"Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment, and the production of new materials, and the FDA has long been involved in their scientific evaluation," said Randall Lutter, Ph.D., deputy commissioner for policy. "Our guidance provides a framework for both GE animals and products made from them to reach the market."
The FDA said the draft guidance describes how the agency regulates heritable rDNA constructs, meaning constructs inherited from one generation to the next. Non-heritable constructs, such as those used for gene therapy to treat individual animals, may be the subject of a subsequent guidance.
For more information, see http://www.fda.gov/cvm/GEAnimals.htm.
Source: Food and Drug Administration
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