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Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #115 (VICH GL22) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1)." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). In order to establish the safety of veterinary drug residues in human food, a number of toxicological evaluations are required, including the assessment of any effects on reproduction. The objective of this guidance is to ensure international harmonization of reproduction testing that is appropriate for the evaluation of effects on reproduction from long-term, low-dose exposures; these effects may be encountered from the presence of veterinary drug residues in food.