Federal Register #FDA-2000-D-0598

FDA Final Guidance on Genotoxicity Testing for Veterinary Drug Residues in Human Food

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued final guidance for industry on harmonized genotoxicity testing for veterinary drug residues in human food. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Guidance Details: - Title: "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)" - Developed in collaboration with the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) - VICH includes regulatory and industry representatives from the European Union, Japan, United States, Australia, New Zealand, Canada, South Africa, United Kingdom, and the World Organisation for Animal Health - Purpose: - Harmonizes international standards for genotoxicity testing of veterinary drug residues - Provides study design recommendations to facilitate mutual acceptance of safety data for determining Acceptable Daily Intakes (ADIs) in human food - Notable Requirements: - No specific products, part numbers, or purchase quantities are mentioned - Notice is informational and not a solicitation or award

Description

The Food and Drug Administration (FDA) announces the availability of final guidance for industry #116 (VICH GL23(R2)) titled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)." This guidance was developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) to ensure international harmonization of genotoxicity testing of veterinary drug residues. The guidance provides study design recommendations to facilitate mutual acceptance of safety data for determining Acceptable Daily Intakes (ADIs) for veterinary drug residues in human food. It reflects the recommendations of the VICH and aims to harmonize technical requirements among regulatory agencies in different countries.

View original listing