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News from the FDA

By ALM Staff | Law Journal Newsletters |
June 29, 2004

New Rules On Development of Veterinary Drugs That Can Affect Food Supplies

Of interest to veterinary medicine manufacturers is a final guidance document issued by the FDA titled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing” (VICH GL28). The guidance was adapted for veterinary use by the International Cooperation on Harmonisation of Technical Require-ments for Registration of Veterinary Medicinal Products (VICH) from a guidance regarding pharmaceuticals for human use. It's intended to help ensure that residues of veterinary drugs in animal products for human consumption are not too carcinogenic and applies to food in the European Union, Japan, and the United States. Copies of the document may be obtained on the Internet from the CVM home page at http://www.fda.gov/cvm. For more information, see Docket No. 2001D-0357 at http://a257.g.akamaitech.net/ 7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-11781.htm

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