Comparability Protocols -Chemistry, Manufacturing, andControls Informationfor New Animal Drugs

Guidance for Industry 

Submit comments on this guidance at any time. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. (See comments on the draft guidance under legacy docket number 2003D-0061). 

For further information regarding this guidance document, contact Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0696; email: dennis.bensley@fda.hhs.gov

Additional copies of this guidance document may be requested from the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at either http://www.fda.gov/AnimalVeterinary/default.htm or http://www.regulations.gov. 

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Comparability Protocols - Chemistry, Manufacturing, and Controls Information for New Animal Drugs
FDA - April 2016
UCM052510.pdf
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