FDA可在年度报告中提出的变更指南中英文对照.docVIP

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FDA可在年度报告中提出的变更指南中英文对照.doc

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201006 FDA行业指南可在年报中报告的CMC已批准生产变更草案（中英文）?? 2013-01-22 16:04:09|??分类：? \o FDA FDA|字号?订阅 ? ?Guidance for Industry 行业指南 CMC Postapproval Manufacturing Changes Reportable in Annual Reports 可在年报中报告的CMC已批准生产变更 DRAFT GUIDANCE 指南草案 This guidance document is being distributed for comment purposes only. 本指南文件仅供征求意见。 Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit 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) Jon E. Clark at 301-796-2400. 关于本草案的问题请联系CDER Jon E. Clark at 301-796-2400 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) June 2010 CMC ? Guidance for Industry 行业指南 CMC Postapproval Manufacturing Changes Reportable in Annual Reports 可在年报中报告的CMC已批准生产变更 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 20993-0002 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) June 2010 TABLE OF CONTENTS I. INTRODUCTION. 介绍1 II. BACKGROUND.背景1 III. DISCUSSION..讨论2 IV. CONTENTS OF ANNUAL REPORT NOTIFICATION.年报通知的内容4 APPENDIX A: CMC POSTAPROVAL MANUFACTURING CHANGES REPORTABLE IN ANNUAL REPORTS 附件A：可在年报中报告的CMC已批准生产变更 ? Guidance for Industry \o [1]?行业指南 CMC Postapproval Manufacturing Changes Reportable in Annual Reports 可在年报中报告的