目标产品概述.docxVIP

Guidance for Industry and Review Staff Target Product Profile — A Strategic Development Process Tool DRAFT GUIDANCE 行业与评审员指南 目标产品概述——战略研发过程的工具 草案 This guidance document is being distributed for comment purposes only.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 suggestionsregarding 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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 theFederal 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 Guida nee for In dustry and Review Staff Target Product Profile — A Strategic Developme nt Process Tool 行业与评审员指南 目标产品概述一一战略研发过程的工具 Additi onal copies are available from: 可从下述地址获得副本： Office of Trai ning and Com mun icatio ns Divisio n of Drug In formatio n, HFD-240 Cen ter for Drug Evaluati on and Research Food and Drug Adm ini strati on 5600 Fishers Lane Rockville, MD 20857(Tel) 301-827-4573 /cder/guida nce/in dex.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 Lane Rockville, MD 20857(电话)301-827-4573 /cder/guida nce/in dex.htm U.S. Departme nt of Health and Huma n ServicesFood and Drug Adm ini strati onCen ter for Drug Evaluati on and Research (CDER) March 2007 Procedural 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 INTRODUCTION 引言 BACKGROUND