May 12, 2015
The U.S. Food and Drug Administration today issued a final guidance for industry (GFI) on genotoxicity testing: #116, Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing.
The guidance recommends a standard battery of tests that can be used for the evaluation of the genotoxicity of veterinary drugs and is intended to facilitate the mutual acceptance of data necessary to establish acceptable daily intakes (ADIs) for veterinary drug residues in human food by the relevant regulatory authorities.
The guidance was developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). VICH is an international body that strives to harmonize technical requirements for veterinary product registration (approval) in the U.S., European Union, and Japan. VICH seeks scientifically based technical procedures for developing pharmaceutical products and aims to reduce differences in technical requirements for drug development among regulatory agencies in different countries.
FDA guidance documents represent the agency’s latest thinking on particular topics, policies and regulatory issues. While guidance documents are prepared primarily for the benefit of industry, they also are used by FDA staff and other stakeholders to understand the agency’s interpretation of regulations and policies.
Although this guidance has been finalized, you can submit comments at any time. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2000-D-0598 in the search box. To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2000-D-0598 on each page of your written comments.
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Notice of Availability of Revised Guidance for Industry; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food; Genotoxicity Testing
- Guidance for Industry #116: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (PDF - 222KB)
Regulations.gov Veterinary International Conference on Harmonization (VICH) Guidance Documents