Zdrowie i gospodarka · 22/03/2004

International Cooperation on Harmonization of Technical Requirements for Approval of Veterinary Medicinal Products; Guidance for Industry on “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing; ” Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry ( 148) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing" (VICH GL32). This guidance has been developed by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This guidance document provides harmonized guidance on the core recommendation for a developmental toxicity study for the safety evaluation of veterinary drug residues in human food.