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GUIDANCE DOCUMENT

CVM GFI #114 (VICH GL21) Effectiveness of Anthelmintics: Specific Recommendations for Poultry-Gallus Gallus June 2002

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

The present guidance for poultry (Gallus gallus) was developed by the Working Group established by the Veterinary International Cooperation on Harmonization (VICH), Anthelmintic Guidances. It should be read in conjunction with the VICH Effectiveness of Anthelmintic: 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.

This guidance for poultry is part of this EAGR and the aim is (1) to be more specific for certain specific issues for poultry 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. Although technical procedures to be followed are not the aim of this guidance, some details are given as until now the pertinent procedures have not been described elsewhere.


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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:

Dockets Management
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-2000-D-0193.

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