Sunday, March 15, 2009

FDA Considers Horses Companion Animals

"February 12, 2009

FDA Reminds Public of Comment Period Deadline for the Draft Guidance for Industry on Anesthetics for Companion Animals

On December 17, 2008, the Food and Drug Administration (FDA) published in the Federal Register the availability of a draft guidance document for industry entitled “Guidance for Industry #192: Anesthetics for Companion Animals.”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. "

Entire article here: FDA Article

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