A Food and Drug Administration final guidance for industry (#141) titled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing" (VICH GL28) is now available. The guidance aims to ensure that carcinogenicity assessments of veterinary drugs are adequate to determine risk for humans exposed to residues of veterinary drugs in human food in the European Union, Japan, and the United States.
The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products adapted the veterinary guidance from a guidance approved by the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use.
In recent years, the FDA has participated in efforts to enhance international harmonization of regulatory requirements and has sought scientifically based, harmonized, technical procedures for the development of pharmaceutical products. The newly available veterinary guidance is the latest outcome of this FDA effort.
Copies of the new veterinary guidance may be obtained from www.fda.gov/cvm/default.html. Individuals can also request a copy by writing to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855. Requestors should send a self-addressed, adhesive label to assist in processing their request.
Individuals can submit comments at www.fda.gov/dockets/ecomments or by writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.