Business · 10/06/2016

FDA Releases Draft Guidance for Oncology Drugs in Companion Animals

The Food and Drug Administration (FDA) has released a draft guidance for industry (GFI) #237 titled "Oncology Drugs for Companion Animals," which provides recommendations for sponsors of investigational oncology drugs for use in companion animals, including dogs, cats, and horses. The guidance also addresses human user safety concerns and outlines the contents of a new animal drug application (NADA) for certain oncology drugs.