风险管理评价指南

GuidanceforIndustryFormatandContentofProposedRiskEvaluationandMitigationStrategies(REMS),REMSAssessments,andProposedREMSModificationsDRAFTGUIDANCEThisguidancedocumentisbeingdistributedforcommentpurposesonly.Commentsandsuggestionsregardingthisdraftdocumentshouldbesubmittedwithin90daysofpublicationintheFederalRegisterofthenoticeannouncingtheavailabilityofthedraftguidance.SubmitcommentstotheDivisionofDocketsManagement(HFA-305),FoodandDrugAdministration,5630FishersLane,rm.1061,Rockville,MD20852.AllcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishesintheFederalRegister.Forquestionsregardingthisdraftdocumentcontact(CDER)KathleenFrost301-796-2380,or(CBER)theOfficeofCommunication,Outreach,andDevelopment(OCOD)at301-827-1800or800-835-4709.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)September2009DrugSafetyGuidanceforIndustryFormatandContentofProposedRiskEvaluationandMitigationStrategies(REMS),REMSAssessments,andProposedREMSModificationsAdditionalcopiesareavailablefrom:OfficeofCommunicationsDivisionofDrugInformation,WO51,Room2201CenterforDrugEvaluationandResearchFoodandDrugAdministration10903NewHampshireAvenueSilverSpring,MD20993-0002Phone:[phone];Fax:[e-mail](OCOD)CenterforBiologicsEvaluationandResearchFoodandDrugAdministration1401RockvillePike,Rockville,MD20852-1448Phone:[phone]or301-827-1800E-mail:[e-mail](CDER)CenterforBiologicsEvaluationandResearch(CBER)September2009DrugSafetyTABLEOFCONTENTSI. INTRODUCTION.............................................................................................................1II. BACKGROUND...............................................................................................................2A.FDAAAandREMS:InitialApprovalandPostapprovalRequirements.................................2B.RelationshipBetweenREMSandRiskMAPs.............................................................................3C.ProductsDeemedtoHaveinEffectanApprovedREMS..........................................................4D.ContentofaREMS........................................................................................................................5E.AssessmentsandModificationsofApprovedREMS..................................................................6F.REMSAreEnforceable.................................................................................................................7III. CONTENTOFAPROPOSEDREMSSUBMISSIONTOFDA.................................7A.ContentoftheProposedREMS....................................................................................................7B.ContentoftheREMSSupportingDocument............................................................................16C.ForeignLanguageREMS............................................................................................................21IV. REMSASSESSMENTANDPROPOSEDREMSMODIFICATIONSUBMISSIONSTOFDA...............................................................................................22V. COMMUNICATINGWITHFDAREGARDINGREMS..........................................23A.SubmissionType..........................................................................................................................23B.DocumentIdentification..............................................................................................................23C.QuestionsaboutREMS...............................................................................................................26GLOSSARY.................................................................................................................................28ATTACHMENTA:EXAMPLEOFAREMSDOCUMENT..............................................30FORAFICTITIOUSDRUG.....................................................................................................30ContainsNonbindingRecommendationsDraft–NotforImplementation12GuidanceforIndustry13FormatandContentofProposedRiskEvaluationand4MitigationStrategies(REMS),REMSAssessments,5andProposedREMSModifications678Thisdraftguidance,whenfinalized,willrepresenttheFoodandDrugAdministration's(FDA's)current9thinkingonthistopic.Itdoesnotcreateorconferanyrightsfororonanypersonanddoesnotoperateto10bindFDAorthepublic.Youcanuseanalternativeapproachiftheapproachsatisfiestherequirementsof11theapplicablestatutesandregulations.Ifyouwanttodiscussanalternativeapproach,contacttheFDA12staffresponsibleforimplementingthisguidance.IfyoucannotidentifytheappropriateFDAstaff,call13theappropriatenumberlistedonthetitlepageofthisguidan