GUIDANCE DOCUMENT
CVM GFI #192 Anesthetics for Companion Animals March 2010
- Docket Number:
- FDA-2008-D-0623
- Issued by:
-
Guidance Issuing OfficeCenter for Veterinary Medicine
This guidance makes recommendations for the development of anesthetic new animal drug products for companion animals (dogs, cats, and horses). The guidance specifically describes what should be considered while planning and executing safety and field studies for the proposed anesthetic. The guidance also includes recommendations on how to analyze and package the collected data for submission to the Center for Veterinary Medicine (CVM).
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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:
Dockets Management
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-2008-D-0623.