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ICH Guidance on Veterinary Drug Residues in Human Food

06/01/2015

Federal Register Notice: FDA is making available a draft guidance for industry entitled Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD) (VICH GL54). It has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products. This draft document is intended to address the nature and types of data that can be useful in determining an ARfD for residues of veterinary drugs, the studies that may generate such data, and how the ARfD may be calculated based on these data. To download this draft guidance, click here. To view this notice, click here.

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