fda指南：anda原料药和制剂稳定性试验问答(201405)

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1、201405FDA指南：ANDA：原料药和制剂稳定性试验问答GuidanceforIndustry行业指南ANDAs:StabilityTestingofDrugSubstancesandProductsQuestionsandAnswersANDA：原料药和制剂稳定性试验问答FinalGUIDANCE最终稿指南U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)May2014Genericsyearsmortgagehousing

2、;4.mortgageregistrationformalitiesarecompleted.(D)pledge1.borrower(includingthepledgor)between18-65yearsofage,withfullcivilcapacity;2.collateralGuidanceforIndustryANDAs:StabilityTestingofDrugSubstancesandProductsQuestionsandAnswersANDA：原料药和制剂稳定性试验问答Additionalcopiesareavailablefrom:OfficeofCommu

3、nicationsDivisionofDrugInformation,WO51,Room2201CenterforDrugEvaluationandResearchFoodandDrugAdministration10903NewHampshireAve.,SilverSpring,MD20993Phone:301-796-3400;Fax:301-847-8714druginfo@fda.hhs.govU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandRe

4、search(CDER)May2014Genericsyearsmortgagehousing;4.mortgageregistrationformalitiesarecompleted.(D)pledge1.borrower(includingthepledgor)between18-65yearsofage,withfullcivilcapacity;2.collateralTABLEOFCONTENTS目录I.INTRODUCTION介绍II.QUESTIONSANDANSWERS提问和回答A.General一般问题B.DrugMasterFile药物主文件.C.DrugPro

5、ductManufacturingandPackaging药品生产和包装D.AmendmentstoPendingANDAApplication未批准ANDA申请的增补E.StabilityStudies稳定性试验.yearsmortgagehousing;4.mortgageregistrationformalitiesarecompleted.(D)pledge1.borrower(includingthepledgor)between18-65yearsofage,withfullcivilcapacity;2.collateralGuidanceforIndustryANDA

6、s:StabilityTestingofDrugSubstancesandProductsQuestionsandAnswersANDA：原料药和制剂稳定性试验问答ThisguidancerepresentstheFoodandDrugAdministration’s(FDA’s)currentthinkingonthistopic.ItdoesnotcreateorconferanyrightsfororonanypersonanddoesnotoperatetobindFDAorthepublic.Youcanuseanalternativeapproachiftheapproa

7、chsatisfiestherequirementsoftheapplicablestatutesandregulations.Ifyouwanttodiscussanalternativeapproach,contacttheFDAstaffresponsibleforimplementingthisguidance.IfyoucannotidentifytheappropriateFDAstaff,calltheappropriatenumberlis