Health and Human Services Department Docket FDA-2022-D-1494 Notice

2026-12684: International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Canines; Guidance for Industry; Availability

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Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #111 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Canines." This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this guidance is to provide study design recommendations specific to canines that will facilitate the universal acceptance of the generated effectiveness data to fulfill the national/regional requirements for anthelmintic drugs in animal species.

The agency’s own summary, as published.

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