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Guidance Issuing OfficeCenter for Veterinary Medicine
This ovine guidance was developed by the Working Group established by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), Anthelmintic Guidances. It should be read in conjunction with Guidance for Industry (GFI) #90 (VICH GL7), “Effectiveness of Anthelmintics: General Recommendations;” 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 GFI #90/VICH GL7 with the aim of simplicity for readers comparing both documents.
The aim of the ovine guidance is: (1) to be more specific for certain specific ovine issues not discussed in the overall guidances; (2) to highlight differences with GFI #90/VICH GL7 on effectiveness data recommendations; and (3) to give explanations for disparities with GFI #90/VICH GL7.
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 sponsors refer to the pertinent procedures described in detail in other published documents, e.g., World Association for the Advancement of Veterinary Parasitology (W.A.A.V.P.) second edition of guidelines for evaluating the efficacy of anthelmintics in ruminants (bovine, ovine, caprine). Veterinary Parasitology 58: 181-213, 1995, and updated versions as they are published.
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
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2022-D-1494.