Federal Register #FDA2022D1494

FDA Releases Final Guidance on Effectiveness of Anthelmintics in Equines and Canines

This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, announces the availability of final guidance documents for industry regarding the effectiveness of anthelmintic drugs in equines (horses) and canines (dogs). - 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 or services are being procured; this is an informational guidance release - Notable Requirements: - The guidance documents were developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) - Guidance provides study design recommendations for effectiveness of anthelmintic drugs in equines and canines - Aims to harmonize international technical requirements for veterinary medicinal products - No procurement, purchase quantities, or part numbers are included in this notice

Description

The Food and Drug Administration (FDA) announces the availability of a final guidance for industry (GFI) #90 entitled "Effectiveness of Anthelmintics: General Recommendations." Developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), this guidance provides study design recommendations to facilitate universal acceptance of effectiveness data for anthelmintic drugs in animal species. The guidance aims to harmonize technical requirements across different national and regional regulatory agencies. Comments on the guidance can be submitted via Regulations.gov.

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