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GUIDANCE DOCUMENT

CVM GFI #113 (VICH GL20) Effectiveness of Anthelmintics: Specific Recommendations for Feline June 2002

Final
Docket Number:
FDA-2000-D-0193
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The present guidance for feline 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 guidance with the aim of simplicity for readers comparing both documents. 

The guidance for feline is part of the EAGR and the aim is: (1) to be more detailed for certain specific issues for feline 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 the pertinent procedures described in detail in other published documents e.g., WAAVP Guidelines for Evaluating the Efficacy of Anthelmintics for Dogs and Cats, Veterinary Parasitology 52: 179-202, 1994.


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All written comments should be identified with this document's docket number: FDA-2000-D-0193.

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