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GUIDANCE DOCUMENT

CVM GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for Equines June 2026

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2022-D-1494
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This equine guidance was developed by the Working Group established by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), Anthelmintic Guidances, and subsequently revised in 2024.  It should be read in conjunction with Guidance for Industry (GFI) #90 (VICH GL7), “Effectiveness of Anthelmintics: General Recommendations,”  which should be referred to for discussion of broad aspects for providing pivotal data to demonstrate product anthelmintic effectiveness.  The present document is structured similarly to GFI #90/VICH GL7 with the aim of simplicity for readers comparing both documents.

The aim of the equine guidance is: (1) to be more specific for certain specific equine issues not discussed in GFI #90/VICH GL7; (2) to highlight differences with GFI #90/VICH GL7 on effectiveness data recommendations; and (3) to give explanations for disparities with GFI #90/VICH GL7.

It is also important to note that technical procedures to be followed in the studies are not the aim of this guidance.  We recommend that sponsors refer to the pertinent procedures described in detail in other published documents, e.g., World association for the advancement of veterinary parasitology (WAAVP): third edition of guideline for evaluating the efficacy of equine anthelmintics. Veterinary Parasitology 303: 109676, 2022, and updated versions as they are published.

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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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