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GUIDANCE DOCUMENT

CVM GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for Equine June 2002

Final
Docket Number:
FDA-2000-D-0135
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The present guidance for equines was developed by the Working Group established by the Veterinary International Co-operation 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 equine is part of this EAGR and the aim is (1) to be more specific for certain issues for equines not discussed in the EAGR; (2) to highlight differences with the EAGR on effectiveness data recommendations and (3) to give explanations for disparities with the EAGR.

It is also important to note that technical procedures to be followed in the studies are not the aim of this guidance. We recommend to the sponsors to refer to the pertinent procedures described in detail in other published documents, e.g., WAAVP Guidances for Evaluating the Effectiveness of Equine Anthelmintics. Veterinary Parasitology, 30: 57-72, 1988.


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Dockets Management
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5630 Fishers Lane, Rm 1061
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All written comments should be identified with this document's docket number: FDA-2000-D-0135.

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