The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #116 (VICH GL23(R2)) titled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)." This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this guidance is to ensure international harmonization of genotoxicity testing of veterinary drug residues.
US Federal Register - FDA Guidance Notices · September 02, 2026
VICH GL23(R2): Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)
Original title: International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2); Guidance for Industry; Availability
FDA announces final guidance harmonizing international genotoxicity testing requirements for veterinary drug residues in human food.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.