International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance on “Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies” (VICH GL22); Availability; Request for Comments

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability for comment of a draft guidance for industry (#115) entitled "Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies" (VICH GL22). This draft guidance has been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal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). This draft VICH guidance document recommends a basic battery of tests that can be used to evaluate the reproduction safety of veterinary drug residues in human food.