目标产品概述.doc

Guidance for Industry and Review StaffTarget Product Profile — A Strategic Development Process Tool DRAFT GUIDANCE 行业与评审员指南 目标产品概述——战略研发过程的工具 草 案 This guidance document is being distributed for comment purposes only. 本指南文件的发布仅供征求意见之用。 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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.?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 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. 有关本草案文件的意见和建议应在联邦注册公布本草案生效之日起60天内递交。将意见递交至食品药品监督管理局档案管理部（HFA-305），地址为：5630 Fishers Lane, rm. 1061, Rockville, MD 20852。所有意见应用联邦注册颁布的生效通知中列出的档案编号进行标识。 For questions regarding this draft document contact Jeanne M. Delasko at 301-796-0900. 如对本草案文件有任何问题，请致电301-796-0900，Jeanne M. Delasko将为您解答疑问。? U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER) March 2007Procedural 美国卫生和人类服务部 食品药品管理局 药品评估和研究中心（CDER） 2007年3月 程序性的 Guidance for Industry and Review StaffTarget Product Profile — A Strategic Development Process Tool 行业与评审员指南 目标产品概述——战略研发过程的工具 Additional copies are available from: 可从下述地址获得副本： Office of Training and CommunicationsDivision of Drug Information, HFD-240Center for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers LaneRockville, MD? 20857(Tel) 301-827-4573/cder/guidance/index.htm 药品信息部的培训和通信办公室，HFD-240 药品研究和评价中心 食品和药品管理局 5600 Fishers LaneRockville, MD? 20857(电话) 301-827-4573 /cder/guidance/index.htm U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER) March 2007Procedural 美国卫生和人类服务部 食品和药品管理局 药品研究和评价中心（CDER） 2007年3月 程序化文件 TABLE OF CONTENTS 目 录 INTRODUCTION 引言 BACKGROUND 背景 DESCRIPTION AND