Docket Number:
FDA-2016-D-1248
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance document makes recommendations to sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses). The guidance discusses the contents of the target animal safety, effectiveness, and labeling technical sections of a new animal drug application (NADA) for oncology drugs administered as single agents. This guidance also includes recommendations on how to address human user safety concerns. For multi-drug regimens, we recommend that you contact the Center for Veterinary Medicine (CVM) to discuss your product development plan.

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All written comments should be identified with this document's docket number: FDA-2016-D-1248.

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