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2018FDA行业指南:优良ANDA申报规范(草案)

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xiaoxiao 发表于 2018-4-26 22:14:59 | 显示全部楼层 |阅读模式

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GoodANDASubmissionPractices

Guidance for Industry
行业指南:优良ANDA申报规范(草案)
DRAFTGUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggesti** regardingthis draft document should be submitted within 60 days ofpublication in the Federal Register ofthe notice announcingtheavailabilityofthe draftguidance.  Submit electronic comments to https://www.regulati**.gov.Submit writtencomments to the DocketsManagement Staff(HFA-305), Foodand Drug Administration, 5630FishersLane, Rm. 1061, Rockville, MD20852.All comments should be identified with thedocket number listed in the notice ofavailabilitythat publishes in the Federal Register.
For questi** regardingthis draft document, contact (CDER)Lisa Bercuat240-402-6902.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
January 2018 Generics
Additionalcopiesareavailablefrom:
OfficeofCommunicati**,DivisionofDrugInformationCenterforDrugEvaluationandResearch

FoodandDrugAdministration

10001NewHampshireAve.,HillandaleBldg.,4thFloorSilverSpring,MD20993-0002
Phone:855-543-3784or301-796-3400;Fax:301-431-6353



Good ANDA Submission Practices

GuidanceforIndustry[1]

行业指南:优良ANDA申报规范(草案)
This draftguidance, when finalized, willrepresentthecurrentthinkingofthe Food  and DrugAdministration (FDA orAgency)on this   topic.Itdoes not establish anyrights foranyperson and   is notbindingon FDA   orthepublic.  Youcan use   an alternative approach   ifitsatisfies   the requirementsoftheapplicablestatutesandregulati**.To discussan alternative approach,contactthe   FDA staffresp**ibleforthis guidance   as listed on thetitle   page.
本指南草案在定稿时将代表FDA对此主题当前的态度。它并不赋予任何人以任何权力,也不对FDA和公众形成约束。只要替代方法满足适用的法律法规要求,你可以使用替代方法。如需对替代方法进行讨论,请联系列在标题页的本指南FDA负责员工。


I.         INTRODUCTION概述
This guidance is intended to assist applicants preparingto submit to FDAabbreviated newdrugapplicati**(ANDAs).  This guidance highlightscommon, recurringdeficiencies that mayleadto adelayin the approvalof anANDA.  It also makes recommendati** to applicants on howtoavoid these deficiencieswith the goal ofminimizingthenumberof reviewcycles necessaryforapproval.
本指南意在帮助申报人准备给FDA的ANDA申报。本指南主要关注了可能会导致ANDA批准延迟的常见重复缺陷,也为申报人给出建议要如何避免这些缺陷,以尽可能减少批准所需的审评轮次。
Ingeneral, FDA’sguidance documents do not establish legallyenforceableresp**ibilities.Instead,guidancesdescribe the Agency’s current thinkingon atopic and should be viewed onlyas recommendati**, unless specific regulatoryorstatutoryrequirements are cited.Theuseofthe word should in Agencyguidances means thatsomethingis suggested or recommended, butnot required.

一般来说,FDA的指南文件并不建立法定强制义务,相反,指南所述的只是当局目前对某个主题的想法,除引用具体法规或法律要求外,均仅应作为建议看待。SHOULD一词在官方指南中表示建议或推荐某事但并非强制。


[1] ThisguidancehasbeenpreparedbytheOfficeofGenericDrugsandtheOfficeofPharmaceuticalQualityintheCenterforDrugEvaluationandResearchattheFoodandDrugAdministration.本指南由FDA的CDER的OGD和OPQ办公室起草。

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小米2015 发表于 2018-5-8 16:06:30 | 显示全部楼层
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