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June 15, 2018

FDA announces availability of final guidance for industry: General principles for evaluating the human food safety of new animal drugs used in food-producing animals

This guidance describes the type of information that the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) recommends sponsors provide to address the human food safety of new animal drugs used in food-producing animals. The human food safety evaluation of new animal drugs used in food-producing animals helps ensure that food derived from treated animals is safe for human consumption. Sponsors are required to furnish to CVM scientific data or information necessary to demonstrate that residues of the new animal drug in the edible tissues of treated animals are safe (see section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)). In general, studies conducted to provide this information must be conducted in accordance with FDA’s Good Laboratory Practice (GLP) regulations. See Title 21, Code of Federal Regulations, part 58 (21 CFR part 58). Comments may be submitted at any time.  Read more

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