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GuidancedocumentsdescribeFDA’sinterpretationoforpolicyonaregulatoryissue(21CFR10.115(b)).Ingeneral,FDA’sguidancedocumentsdonotestablishlegallyenforceableresponsibilitiesandthusarenotbindingonFDAorthepublic.Instead,guidancesdescribetheAgency’scurrentthinkingonatopicandshouldbeviewedonlyasrecommendations,unlessspecificregulatoryorstatutoryrequirementsarecited.Youcanuseanalternativeapproachiftheapproachsatisfiestherequirementsoftheapplicablestatutesandregulations.
ThisfeatureisprovidedtogiveaconvenientwaytosearchforallFDAguidancedocumentsfromasinglelocation.
Consistentwithsection2505(c)oftheConsolidatedAppropriationsAct,2023,FDAsolicitedpubliccommentontheDraftReportandPlanfromabroadrangeofinterestedparties.Followingthecloseofthepubliccommentperiod,FDApreparedthefinalreportandplan,availablebelow.
CenterandOfficeGuidanceAgendasareavailablethroughthelinksbelow:
AnimalandVeterinary
FoodsProgram
MedicalDevicesandRadiation-EmittingProducts
Drugs
OfficeoftheChiefScientist
Tobacco
Vaccines,Blood&Biologics
Thereareseveralopportunitiestoprovideinputontopicsforguidancedocumentdevelopment,includingtopicsforpotentialfutureguidancedocuments,viaformalandinformalchannels.FDACentersandOfficespublishannualGuidanceAgendas,whichlistpossibletopicsforfutureguidancedocumentdevelopmentorrevisionduringtheupcomingyear.However,theguidancedevelopmentprocessisfluidandchangesdependingonpublichealthneedsandAgencyresources.TheGuidanceAgendasdonotbindFDAtoalistoftopicsorobligateFDAtoissueeveryguidancedocumentonanAgenda,especiallygiventhatcompetingprioritiesmayariseduringtheyear.Inaddition,aCenterorOfficeisnotprecludedfromissuingguidancedocumentsontopicsthatarenotlistedontheirGuidanceAgendas.
BeginninginJanuary2025,forthoseCentersandOfficesthatissueaguidanceagendaonaCalendarYearbasis,FDAwillpublishaNoticeofAvailabilityintheFederalRegisterannouncingtheavailabilityofannualGuidanceAgendasandprovidinginformationabouthowtocommentontheAgenda.
YoucansuggestareasforguidancedocumentdevelopmentbycommentingonaGuidanceAgendaorbycontactingtheCenterorOfficethatisresponsiblefortheregulatoryactivitycoveredbytheguidancedocument.Yoursuggestionsshouldaddresswhyaguidancedocumentisnecessary.
Youcan,atanytime,suggestthatFDAreviseorwithdrawaguidancedocumentbycontactingtheCenterorOfficethatisresponsiblefortheregulatoryactivitycoveredbytheguidancedocument.Yoursuggestionshouldaddresswhytheguidancedocumentshouldberevisedorwithdrawnand,ifapplicable,howitshouldberevised.
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