CDERGUIDANCES
NEW/REVISED/WITHDRAWN
1/1/2014–3/31/2014
(Sortedbydate)
TitleSubject
Levelat
Dateof
Issue
Publication/
Withdrawal
DateStatus
QualificationProcessforDrugDevelopment
Tools
Procedural/Clinical
MedicalLevel11/7/2014New
PulmonaryDiseaseToolforMeasurementof
SymptomsofAcuteBacterialExacerbationof
ChronicBronchitisinPatientsWithChronic
ObstructivePulmonaryDisease
Procedural/Clinical
MedicalDraftLevel11/10/2014New
Community-AcquiredPneumonia—
Developing
AntimicrobialDrugsforTreatment
Clinical/Anitmicrobial
DraftLevel11/10/2014Revised
FulfillingRegulatoryRequirementsfor
PostmarketingSubmissionsofInteractive
PromotionalMediaforPrescriptionHumanand
AnimalDrugsandBiologicsAdvertisingDraftLevel11/14/2014New
DearHealthCareProviderLetters:Improving
CommunicationofImportantSafety
InformationProceduralLevel11/23/2014New
ProvidingSubmissionsinElectronicFormat--
StandardizedStudyData
Electronic
SubmissionsDraftLevel12/6/2014Revised
ProvidingRegulatorySubmissionsin
ElectronicFormat—SubmissionsUnder
Section745A(a)oftheFederalFood,Drug,
andCosmeticAct
Electronic
SubmissionsDraftLevel12/6/2014New
AnalgesicIndications:DevelopingDrugand
BiologicalProductsClinical/MedicalDraftLevel12/6/2014New
ProvidingRegulatorySubmissionsin
ElectronicFormat--ReceiptDate
Electronic
SubmissionsLevel12/7/2014New
AnalyticalProceduresandMethodsValidation
forDrugsandBiologics
Chemistry,
Manufacturingand
Controls(CMC)DraftLevel12/19/2014New
NewChemicalEntityExclusivity
DeterminationsforCertainFixed-Combination
DrugProductsProceduralDraftLevel12/24/2014New
E2B(R3)ElectronicTransmissionofIndividual
CaseSafetyReportsImplementationGuide
—DataElementsandMessageSpecification;
andAppendixtotheImplementationGuide—
BackwardsandForwardsCompatibility10ICHEfficacyDraftLevel12/24/2014Revised
AntiviralProductDevelopment-Conducting
and
SubmittingVirologyStudiestotheAgency:
GuidanceforSubmittingHIV-1Resistance
Data:AttachmenttotheGuidance
Clinical/Anitmicrobial
DraftLevel12/28/2014New
DistributingScientificandMedicalPublications
onUnapprovedNewUses—Recommended
Practices-RevisedGuidanceProceduralDraftLevel13/3/2014Revised
CMCPostapprovalManufacturingChangesTo
BeDocumentedinAnnualReports
Chemistry,
Manufacturingand
Controls(CMC)Level13/5/2014New
ChronicFatigueSyndrome/Myalgic
Encephalomyelitis:DevelopingDrugProducts
forTreatmentClincial/MedicalDraftLevel13/11/2014New
AllowableExcessVolumeandLabeledVialFill
SizeinInjectableDrugandBiologicalProducts
Chemistry,
Manufacturingand
Controls(CMC)DraftLevel13/14/2014New
BioavailabilityandBioequivalenceStudies
SubmittedinNDAsorINDs—General
Considerations
Biopharmaceutics
DraftLevel13/18/2014New
LabelingforHumanPrescriptionDrugand
BiologicalProductsApprovedUnderthe
AcceleratedApprovalRegulatoryPathwayLabelingDraftLevel13/25/2014New
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