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CVM GFI #95 (VICH GL12) Efficacy of Anthelmintics: Specific Recommendations for Bovines March 2001

Docket Number:
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

These guidances for bovine were developed by the Working Group established by the Veterinary International Cooperation on Harmonization (VICH), Anthelmintic Guidances. They 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 guidances for bovine are part of this EAGR and the aim is (1) to be more specific for certain specific issues for bovine not discussed in the overall guidances; (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 that the sponsors refer to the pertinent procedures described in detail in other published documents e.g. WAAVP Second Edition of Guidances for Evaluating the Effectiveness of Anthelmintics in Ruminants (Bovine, Ovine, Caprine) Veterinary Parasitology 58: 181-213, 1995.

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All written comments should be identified with this document's docket number: FDA-1999-D-0188.


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