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GUIDANCE DOCUMENT

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

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-1494
Issued by:
Guidance Issuing Office
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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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-1494.

Questions?

Contact Point
Aimee Phillippi-Taylor
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-114
Rockville, MD 20855
aimee.phillippi-taylor@fda.hhs.gov
240-402-0601
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