The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #95 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Bovines." 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 bovines that will facilitate the universal acceptance of the generated effectiveness data to fulfill the national/regional requirements for anthelmintic drugs in animal species.
US Federal Register - FDA Guidance Notices · June 24, 2026
VICH GFI #95: Effectiveness of Anthelmintics: Specific Recommendations for Bovines
Original title: International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Bovines; Guidance for Industry; Availability
FDA announces final guidance on study design for anthelmintic effectiveness in cattle to harmonise international registration requirements.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.