505b2-coverage

\\CDFDA\COMMON\CDERGUID\2853DFT.DOC7/20/99GuidanceforIndustryApplicationsCoveredbySection505(b)(2)DRAFTGUIDANCEThisguidancedocumentisbeingdistributedforcommentpurposesonly.Commentsandsuggestionsregardingthisdraftdocumentshouldbesubmittedwithin60daysofpublicationoftheFederalRegisternoticeannouncingtheavailabilityofthedraftguidance.SubmitcommentstoDocketsManagementBranch(HFA-305),FoodandDrugAdministration,5630FishersLane,rm.1061,Rockville,MD20857.AllcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishesintheFederalRegister.ForquestionsonthecontentofthedraftdocumentcontactVirginiaBeakes,[phone].U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)October1999\\CDFDA\COMMON\CDERGUID\2853DFT.DOC7/20/99GuidanceforIndustryApplicationsCoveredbySection505(b)(2)DRAFTGUIDANCEForadditionalcopies,contact:DrugInformationBranchDivisionofCommunicationsManagement,HFD-210CenterforDrugEvaluationandResearch(CDER)5600FishersLaneRockville,MD20857(Tel)301-827-4573(CDER)October1999\\CDFDA\COMMON\CDERGUID\2853DFT.DOC7/20/99TableofContentsI.WHATISTHEPURPOSEOFTHISGUIDANCE?...........................................................................................................1II.WHATISA505(B)(2)APPLICATION?............................................................................................................................2A.WHATTYPEOFINFORMATIONCANANAPPLICANTRELYON?........................................................................................2B.WHATKINDOFAPPLICATIONCANBESUBMITTEDASA505(B)(2)APPLICATION?........................................................3III.WHATARESOMEEXAMPLESOF505(B)(2)APPLICATIONS?...............................................................................4IV.WHATCAN'TBESUBMITTEDAS505(B)(2)APPLICATIONS?................................................................................6V.WHYDOESITMATTERIFANNDAISA505(B)(2)APPLICATION?......................................................................6VI.PATENTANDEXCLUSIVITYPROTECTIONSTHATCOULDAFFECTA505(B)(2)APPLICATION.................7A.WHATTYPEOFPATENTAND/OREXCLUSIVITYPROTECTIONISA505(B)(2)APPLICATIONELIGIBLEFOR?................7B.WHATCOULDDELAYTHEAPPROVALORFILINGOFA505(B)(2)APPLICATION?...........................................................7VII.WHATSHOULDBEINCLUDEDIN505(B)(2)APPLICATIONS?...........................................................................7REFERENCES..................................................................................................................................................................................10GLOSSARY.....................................................................................................................................................................................11Draft-NotforImplementation\\CDFDA\COMMON\CDERGUID\2853DFT.DOC10/04/991GUIDANCEFORINDUSTRY1ApplicationsCoveredbySection505(b)(2)I.WHATISTHEPURPOSEOFTHISGUIDANCE?Thisguidanceidentifiesthetypesofapplicationsthatarecoveredbysection505(b)(2)oftheFederalFood,Drug,andCosmeticAct(theAct).A505(b)(2)applicationisanewdrugapplication(NDA)describedinsection505(b)(2)oftheAct.Itissubmittedundersection505(b)(1)oftheActandapprovedundersection505(c)oftheAct.ThisguidancealsoprovidesfurtherinformationandamplificationregardingFDA'sregulationsat21CFR314.54.Section505oftheActdescribesthreetypesofnewdrugapplications:(1)anapplicationthatcontainsfullreportsofinvestigationsofsafetyandeffectiveness(section505(b)(1));(2)anapplicationthatcontainsfullreportsofinvestigationsofsafetyandeffectivenessbutwhereatleastsomeoftheinformationrequiredforapprovalcomesfromstudiesnotconductedbyorfortheapplicantandforwhichtheapplicanthasnotobtainedarightofreference(section505(b)(2));and(3)anapplicationthatcontainsinformationtoshowthattheproposedproductisidenticalinactiveingredient,dosageform,strength,routeofadministration,labeling,quality,performancecharacteristics,andintendeduse,amongotherthings,toapreviouslyapprovedproduct(section505(j)).Notethatasupplementtoanapplicationisanewdrugapplication.Section505(b)(2)wasaddedtotheActbytheDrugPriceCompetitionandPatentTermRestorationActof1984(Hatch-WaxmanAmendments).ThisprovisionexpresslypermitsFDAtorely,forapprovalofanNDA,ondatanotdevelopedbytheapplicant.Sections505(b)(2)and(j)togetherreplacedFDA'spaperNDApolicy,whichhadpermittedanapplicanttorelyonstudiespublishedinthescientificliteraturetodemonstratethesafetyandeffectivenessofduplicatesofcertainpost-1962pioneerdrugproducts(see46FR27396,May19,1981).EnactmentofthegenericdrugapprovalprovisionoftheHatch-WaxmanAmendmentsendedtheneedforapprovalsofduplicatedrugsthroughthepaperNDAprocessbypermittingapprovalunder505(j)ofduplicatesofapproveddrugs(listed1ThisguidancehasbeenpreparedbytheCenterforDrugEvaluationandResearch(CDER)attheFoodandDr