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Guidance Issuing OfficeCenter for Veterinary Medicine
The present guidance for canine was developed by the Working Group that was established by the Veterinary International Cooperation on Harmonization (VICH), Anthelmintic Guidances. It should be read in conjunction with the VICH Effectiveness of Anthelmintics: General Recommendations (EAGR) which should be referred to for discussion of broad aspects for providing pivotal data to demonstrate product anthelmintic effectiveness. The present document is structured similarly to the EAGR with the aim of simplicity for readers comparing both documents.
The guidance for canine is part of the EAGR and the aim is: (1) to be more detailed for certain specific issues for canines not discussed in the EAGR; (2) to highlight differences with the EAGR on data recommendations and (3) to give explanations for disparities with the EAGR guidance.
It is important to note that technical procedures to be followed in the studies are not the aim of this guidance. We recommend that the sponsors refer to pertinent procedures described in detail in other published documents, e.g., WAAVP Guidelines for Evaluating the Effectiveness of Anthelmintics for Dogs and Cats, Veterinary Parasitology 52: 179-202, 1994.
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
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All written comments should be identified with this document's docket number: FDA-2000-D-0135.