June 9, 2016
The U.S. Food and Drug Administration is releasing recommendations for sponsors of investigational oncology drugs for use as single agents in companion animals (e.g., dogs, cats, and horses) on the contents of their New Animal Drug Application (NADA).
The draft guidance discusses the contents of the target animal safety, effectiveness, and labeling technical sections of the NADA, and also includes recommendations on how to address human user safety concerns. For multi-drug regimens, the draft guidance recommends that sponsors contact the Center for Veterinary Medicine (CVM) to discuss their product development plan.
The FDA is accepting public comments on the draft guidance beginning on June 10, 2016. Although members of the public may comment on a guidance document at any time, you should submit comments by August 9, 2016 to ensure that FDA considers a comment before beginning work on the final version of the guidance. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2016-D-1248 in the search box.
To submit comments to the docket by mail, use the address below. Be sure to include docket number FDA-2016-D-1248 on each page of your written comments.
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
- Federal Register Notice of Availability of Final Guidance for Industry; Oncology Drugs for Companion Animals
- Federal Register Notice of Availability of Draft Guidance for Industry; Oncology Drugs for Companion Animals
- Guidance for Industry #237 - Oncology Drugs for Companion Animals
- Regulations.gov: please note that the public comment period opens on June 10, 2016.