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GUIDANCE DOCUMENT

CVM GFI #237 Oncology Drugs for Companion Animals August 2017

Final

CVM GFI #237 Oncology Drugs for Companion Animals

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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
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-2016-D-1248.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002