CVM GFI #90 (VICH GL7) Effectiveness of Anthelmintics: General Recommendations August 2022

GUIDANCE DOCUMENT

• Docket Number: FDA-2022-D-1494
• Issued by: Center for Veterinary Medicine

The objective of this guidance is to provide study design recommendations that will facilitate universal acceptance of the generated effectiveness data to fulfill the national/regional requirements for anthelmintic drugs in veterinary species in the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) regions.

This guidance provides general recommendations for the design of effectiveness studies for anthelmintics, applicable to the most common veterinary species.  The guidance includes two sections. The General Elements section includes: good clinical practice, evaluation of effectiveness data, types of infection and parasite strains, product equivalence, recommendations for the calculation of effectiveness, standards of effectiveness, the definition of helminth claims, and an approach to new indications. The Specific Evaluation Studies section describes: dose determination, dose confirmation, field, and persistent effectiveness studies.

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