International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies To Establish Product Withdrawal Periods; Revised Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (GFI #207) entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods'' (VICH GL48(R)). This revised guidance, which provides minor updates to a final guidance on the same topic for which a notice of availability was published in the Federal Register of September 15, 2011 (2011 guidance), has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revised VICH guidance is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements.