CVM GFI #147 (VICH GL31) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (90 Day) Toxicity Testing July 2006
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Guidance Issuing OfficeCenter for Veterinary Medicine
A variety of toxicological evaluations are performed to establish the safety of veterinary drug residues in human food. The objective of this guidance is to establish recommendations for internationally harmonized 90-day repeat-dose testing.
The current guidance is one of a series of guidances developed to facilitate the mutual acceptance of safety data for the determination of acceptable daily intakes (ADIs) for veterinary drug residues in human food.
Although this guidance recommends a framework for 90-day toxicity testing of veterinary drugs, it is important that the design of the tests remain flexible. It is recommended that tests be tailored to adequately establish the dose-response and a no-observed adverse effect level (NOAEL) for toxicity following 90-day compound treatment.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2002-D-0091.