202155Orig1s000OtherR

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1、CENTERFORDRUGEVALUATIONANDRESEARCHAPPLICATIONNUMBER:202155Orig1s000OTHERREVIEW(S)SelectedRequirementsofPrescribingInformationHighlights(HL)GENERALFORMATYES1.Highlights(HL)mustbeintwo-columnformat,with½inchmarginsonallsidesandinaminimumof8-pointfont.Comment:2.ThelengthofHL

2、mustbelessthanorequaltoone-halfpage(theHLBoxedWarningdoesnotYEScountagainsttheone-halfpagerequirement)unlessawaiverhasbeenisgrantedinaprevioussubmission(i.e.,theapplicationbeingreviewedisanefficacysupplement).Instructionstocompletethisitem:IfthelengthoftheHLislessthanoreq

3、ualtoone-halfpagethenselect“YES”inthedrop-downmenubecausethisitemmeetstherequirement.However,ifHLislongerthanone-halfpage:FortheFilingPeriod(forRPMs)Forefficacysupplements:Ifawaiverwaspreviouslygranted,select“YES”inthedrop-downmenubecausethisitemmeetstherequirement.For

4、NDAs/BLAsandPLRconversions:Select“NO”inthedrop-downmenubecausethisitemdoesnotmeettherequirement(deficiency).TheRPMnotifiestheCross-DisciplineTeamLeader(CDTL)oftheexcessiveHLlengthandtheCDTLdeterminesifthisdeficiencyisincludedinthe74-dayoradvicelettertotheapplicant.Forthe

5、End-ofCyclePeriod(forSEALDreviewers)TheSEALDreviewerdocuments(basedoninformationreceivedfromtheRPM)thatawaiverhasbeenpreviouslygrantedorwillbegrantedbythereviewdivisionintheapprovalletter.Comment:YES3.AllheadingsinHLmustbepresentedinthecenterofahorizontalline,inUPPER-CAS

6、Elettersandbolded.Comment:YES4.WhitespacemustbepresentbeforeeachmajorheadinginHL.Comment:NO5.EachsummarizedstatementinHLmustreferencethesection(s)orsubsection(s)oftheFullPrescribingInformation(FPI)thatcontainsmoredetailedinformation.Thepreferredformatisthenumericalidentif

7、ierinparenthesis[e.g.,(1.1)]attheendofeachinformationsummary(e.g.endofeachbullet).Comment:UnderD&A,thesecondbulletshouldreference2.2;inDIthereferencesshouldbe7.1underthefirstbulletand7.2underthesecondbullet.6.SectionheadingsarepresentedinthefollowingorderinHL:YESSectionRe

8、quired/OptionalHighlightsHeadingRequiredHighlightsLimitationStatementRequiredProductTitleRequ