美国FDA 指导原则 CVM GFI 156可比性协议新动物药物的化学制造和控制信息 英文原版.pdfVIP

#156 Guidance for Industry Comparability Protocols - Chemistry, Manufacturing, and Controls Information for New Animal Drugs Submit comments on this guidance at any time. Submit electronic comments on the guidance to . 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 (See comments on the draft guidance under legacy docket number 2003D-0061).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@. 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 /AnimalVeterinary/default.htm or . U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine April 2016 Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION 4 II. BACKGROUND 4 A. What is a Comparability Protocol? 6 B. What is the Benefit of Using a Comparability Protocol? 6 C. Why is a Guidance on Comparability Protocols Being Provided? 6 D. Where Can More Information on Postapproval Changes and Demonstration