20138 FDA指南：ANDA：原料药和制剂稳定性试验问答(中英文).docx

201308 FDA指南：ANDA：原料药和制剂稳定性试验问答（中英文）?? ? ?Guidance for Industry?行业指南 ANDAs: Stability Testing of Drug Substances and Products Questions and Answers ANDA：原料药和制剂稳定性试验问答 DRAFT GUIDANCE 指南草案 This guidance document is being distributed for comment purposes only. 本指南文件发布仅供讨论。 Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the?Federal Register?of the notice announcing the availability of the draft guidance. Submit electronic comments to?. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 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 draft document contact (CDER) Radhika Rajagopalan 240-276-8546. U.S.?Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) August 2013 Generics Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Questions and Answers ANDA：原料药和制剂稳定性试验问答 Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 druginfo@ /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S.?Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) August 2013 Generics?Contains Nonbinding Recommendations?Draft — Not for Implementation TABLE OF CONTENTS I. INTRODUCTION?介绍 II. QUESTIONS AND ANSWERS?问与答 A. General?一般问题 B. Drug Master File?药物主文件. C. Drug Product Manufacturing and Packaging?药品生产和包装 D. Amendments to Pending ANDA Application?未批准ANDA申请的增补 E. Stability Studies?稳定性试验. Guidance for Industry[1] ANDAs: Stability Testing of Drug Sub