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Guidance on Veterinary Drug Residue Depletion Studies


Federal Register Notice: FDA is making available a revised guidance for industry 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)). It provides minor updates to a final guidance on the same topic for which a notice of availability was published in the 9/15/11 Federal Register developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). It 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. To download this guidance, click here. To view this notice, click here.