Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #187 entitled "Regulation of Intentionally Altered Genomic DNA in Animals." This draft guidance revises GFI #187 entitled "Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs" (current GFI #187). Current GFI #187 clarifies FDA's requirements and recommendations for producers and developers of genetically engineered (GE) animals and their products. It describes how the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) apply with respect to GE animals. This draft revision of current GFI #187 expands the scope of the guidance to include animals intentionally altered through use of genome editing techniques. The draft revised GFI #187 now applies to "those animals whose genomes have been intentionally altered using modern molecular technologies." The Agency is seeking comment on the draft revised GFI #187, including the nomenclature that best describes these animals and on any existing empirical evidence indicating that certain types of genome editing may pose minimal risk.