International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological Acceptable Daily Intake;” Availability

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The Food and Drug Administration (FDA) is announcing the availability for comments of a draft guidance document for industry ([numsign]159) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI" (VICH GL-36). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document provides guidance for assessing the human food safety of residues from veterinary antimicrobial drugs with regard to effects on the human intestinal flora.