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GUIDANCE DOCUMENT

CVM GFI #110 (VICH GL16) Effectiveness of Anthelmintics: Specific Recommendations for Porcines 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Download the Draft Guidance Document Read the Federal Register Notice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Not for implementation.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 present guidance for porcines was developed by the Working Group established by the Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), Anthelmintic Guidances. 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 porcine guidance is: (1) to be more specific for certain specific porcine 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) Second Edition of Guidelines for Evaluating the Effectiveness of Anthelmintics in Swine. Veterinary Parasitology 141: 138-149, 2006, and updated versions as they are published.

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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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