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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Reminds Public of Comment Period Deadline for the Draft Guidance for Industry on Anesthetics for Companion Animals

February 12, 2009

On December 17, 2008, the Food and Drug Administration (FDA) published in the Federal Register the availability of a draft guidance document for industry entitled "Guidance for Industry #192: Anesthetics for Companion Animals". The comment period for the guidance closes on March 2, 2009.

The purpose of the guidance document is to provide industry with FDA’s recommendations for the development of new animal anesthetic drug products for companion animals (dogs, cats, and horses). The guidance discusses information that sponsors should consider when planning and conducting safety and field studies for their proposed drug product. The guidance also provides recommendations on how to analyze the study data and how to present the collected data in an organized package to CVM.

The draft guidance, once finalized, will represent the Agency’s current thinking on the development of companion animal general anesthetic (injectable or inhalational) drug products.

The draft guidance document is available at http://www.fda.gov/cvm/Guidance/guide192.pdf. The federal register notice can be found at: http://edocket.access.gpo.gov/2008/E8-29953.htm.

Interested persons may submit written comments on or before March 2, 2009, to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted to: http://www.regulations.gov/. Identify all submissions to the docket with the following docket number: 2008D-0623.

For additional information about the draft guidance, please contact Dr. Germaine Connolly at FDA’s Center for Veterinary Medicine, 240-276-8331, germaine.connolly@fda.hhs.gov.

 

Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

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Rockville, MD 20855