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Federal Register #FDA-2022-D-1494

FDA Releases Final Guidance on Effectiveness of Anthelmintics in Felines

Buyer

Food and Drug Administration

Posted

June 24, 2026

Identifier

FDA-2022-D-1494

This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, announces the release of final guidance for industry regarding the effectiveness of anthelmintic drugs in felines. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - No specific OEMs or vendors are mentioned - Products/Services Requested: - No products, part numbers, or purchase quantities are specified - The notice pertains to guidance for study design and data requirements for anthelmintic drugs in felines - Unique or Notable Requirements: - The guidance was developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) - Aims to harmonize international requirements for veterinary medicinal product registration - Focuses on study design recommendations for effectiveness data in felines - Supports universal acceptance of data for regulatory submissions - No procurement, solicitation, or award is associated with this notice; it is informational only

Description

The Food and Drug Administration (FDA) announces the availability of final guidance for industry (GFI) #110 titled "Effectiveness of Anthelmintics: Specific Recommendations for Porcines." This guidance, developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), provides study design recommendations specific to porcines. The objective is to facilitate universal acceptance of effectiveness data to meet national and regional requirements for anthelmintic drugs in animal species. The guidance finalizes a draft from August 2022 and aims to harmonize technical requirements internationally.

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