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Product safetyFDAUnited StatesImports

Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; Availability

18 September 2026

In plain English

FDA announces draft Guidance for Industry #298 (VICH GL62) on target animal safety evaluation for veterinary monoclonal antibody products, part of international harmonization efforts.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
18 September 2026
For
Imports
Where it applies
United States

From the notice

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #298 (VICH GL62) titled "Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance contributes to the international harmonization of methods used
The full text is at the source

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