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Guidance Issuing OfficeCenter for Veterinary Medicine
A number of toxicological evaluations are recommended to establish the safety of veterinary drug residues in human food, including the identification of any potential effects on human prenatal development. The objective of this guidance is to recommend that developmental toxicity assessment be performed according to an internationally harmonized approach. This guidance describes a test designed to provide information concerning the effects on the pregnant test animal and on the developing organism following prenatal exposure to this test animal.
The current guidance is one of a series of guidances developed to facilitate the mutual acceptance of safety data necessary for the determination of acceptable daily intakes (ADIs) for veterinary drug residues in human food. This guidance should be read in conjunction with the guidance on the general approach for the safety evaluation of veterinary drug residues in human food (VICH GL33).
This document provides guidance for developmental toxicity testing for those veterinary medicinal products used in food-producing animals. However, it does not limit the studies that may be performed to establish the safety of residues in human food with respect to developmental toxicity. The guidance does not preclude the possibility of alternative approaches that may offer an equivalent assurance of safety, including scientifically based reasons as to why developmental toxicity data may not need to be provided.
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-0090.