“Draft revised GFI #187 is intended to clarify that, unless otherwise excluded, the altered genomic DNA in an animal (referred to in this document as ‘‘animals with intentionally altered genomic DNA’’) that is intended to affect the structure or function of the body of the animal or, in some cases, to diagnose, cure, mitigate, treat, or prevent disease in the animal, meets the drug definition in section 201(g) of the FD&C Act.” U.S. Food & Drug Administration, Notice, “Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Availability,” 82 Fed. Reg. 6561 (January 19, 2017),
available at <
https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-00839.pdf> (last visited February 5, 2018).
+(last+visited+February+5,+2018).>Google Scholar