Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease; Draft Guidance for Industry; Availability
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #251 entitled "Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease." This draft guidance, when finalized, will set forth FDA's policy regarding heritable intentional genomic alterations (IGAs) in animals of food- producing species, such as swine and rabbits, that are intended to be marketed for use as models of human or animal disease in biomedical research under contained and controlled conditions. The draft guidance describes the conditions under which we generally may not expect developers of IGAs in animal models of disease to submit an application to FDA's Center for Veterinary Medicine (CVM) or to get our approval before marketing their animals following CVM's prior review of risk factor data.
Abstract as published in the Federal Register.
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