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Zdrowie i gospodarka · 25/05/2004

International Cooperation on Harmonisation 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: Carcinogenicity Testing; Availability

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry ( 141) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing" (VICH GL28). This guidance has been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) from a guidance regarding pharmaceuticals for human use, which was adopted by the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use (ICH). The objective of this VICH guidance document is to help ensure that the assessment of carcinogenic potential is appropriate to human exposure to residues of veterinary drugs in human food in the European Union, Japan, and the United States.

Source: Federal Register — Food and Drug AdministrationOpen original release →