Zdrowie i gospodarka · 23/10/2003

International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing;” Availability

The Food and Drug Administration (FDA) is announcing the availability for comments of a draft guidance document for industry ([numsign]160) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing" (VICH GL-37). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal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 establishes recommendations for internationally harmonized repeat-dose chronic toxicity testing.