FDA Draft: GM Animals Under the Microscope

FDA Draft: GM Animals Under the Microscope


The US Food and Drug Administration (FDA) have released a guidance document which is intended to clarify the FDA’s regulatory authority in the field of genetically modified animals, as well as the requirements and recommendations for producers of 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The comment period for the draft guidance, titled “The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs,” runs for 60 days and closes Nov. 18, 2008. The 25-page document is available online at http://www.fda.gov/cvm/GEAnimals.htm.

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