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GUIDANCE DOCUMENT

CVM GFI #298 (VICH GL62) – Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products September 2026

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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-2026-D-7233

Docket Number:
FDA-2026-D-7233
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guideline contributes to the international harmonization of methods used for the target animal safety (TAS) evaluation of veterinary monoclonal antibody products (VMAPs) and aids in preparing and conducting VMAP TAS studies under laboratory and field conditions. A harmonized standard is intended to aid in development of mutually acceptable VMAP TAS programs. It is expected that harmonized guidance will accelerate the development and commercialization of novel VMAPs, leading to increased innovation and access to such products in veterinary medicine.

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