FDA指南：ANDA原料药和制剂稳定性试验问答(201405)

201405 FDA 指南：ANDA：原料药和制剂稳定性试验问答 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 Final GUIDANCE 最终稿指南 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) May 2014 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 ****************.gov U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) May 2014 Generics TABLE OF CONTENTS 目录 I. INTRODUCTION 介绍 II. QUESTIONS AND ANSWERS 提问和回答 A. General 一般问题 B. Dru g Master File 药物主文件. C. Dru g Produ ct Manu factu ring 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 Stu dies 稳定性试验. 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 This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff...