Guidance for Industry Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section Of Animal Drug Applications
Draft Guidance This guidance is being distributed for comment purposes only. Submit comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit electronic comments 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. For questions regarding this document, contact Julie Bailey, Center for Veterinary Medicine (HFV-145), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, (240) 402-0700, e-mail: [email protected]. Additional copies of this draft guidance document may be requested from the Policy and Regulations Staff, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at http://www.fda.gov/AnimalVeterinary/default.htm or http://www.regulations.gov.
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