2024
Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence
Mooghali M, Zhou T, Ross J. Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence. BMJ Open 2024, 14: e090376. PMID: 39461853, PMCID: PMC11529451, DOI: 10.1136/bmjopen-2024-090376.Peer-Reviewed Original ResearchConceptsPhase 2 trialPhase 3 trialBox warningAtrial fibrillation patientsPostmarketing evidenceEvidence of safetyOral anticoagulantsFibrillation patientsPostmarketing studiesCross-sectional analysisDegree of concordanceStroke preventionStudy requirementsPostmarketingEfficacy evidenceRegulatory agenciesDrugPostmarketing requirementsInterpretation of resultsEfficacyHealth CanadaSample sizeSafety evidenceConcordanceEndpoint
2023
US Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics
Eadie A, MacGregor A, Wallach J, Ross J, Herder M. US Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics. BMJ Evidence-Based Medicine 2023, 28: 151-156. PMID: 36944478, DOI: 10.1136/bmjebm-2022-112005.Peer-Reviewed Original ResearchConceptsNovel therapeuticsNew therapeuticsUS FoodReviewer disagreementTherapeutic approvalsFDA safety communicationCross-sectional studyBlack box warningPatient populationBox warningDrug AdministrationDrug approvalFDA reviewSafety actionsRegulatory approvalTherapeuticsFDAApprovalMarket approvalFDA reviewersReviewersInstances of disagreementReviewActionAdministration
2021
Association of Fluoroquinolone Prescribing Rates With Black Box Warnings from the US Food and Drug Administration
Sankar A, Swanson KM, Zhou J, Jena AB, Ross JS, Shah ND, Karaca-Mandic P. Association of Fluoroquinolone Prescribing Rates With Black Box Warnings from the US Food and Drug Administration. JAMA Network Open 2021, 4: e2136662. PMID: 34851398, PMCID: PMC8637256, DOI: 10.1001/jamanetworkopen.2021.36662.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAmbulatory CareAnti-Bacterial AgentsBronchitisCross-Sectional StudiesDrug LabelingDrug PrescriptionsFemaleFluoroquinolonesHealth Plan ImplementationHumansInterrupted Time Series AnalysisMaleMedicareMiddle AgedPractice Patterns, Physicians'SinusitisUnited StatesUnited States Food and Drug AdministrationUrinary Tract InfectionsConceptsPrescribing of fluoroquinolonesCross-sectional studyBlack box warningFDA warningCare physiciansPrescribing levelsBox warningMAIN OUTCOMEUS FoodDrug AdministrationMedicare administrative claims dataUncomplicated urinary tract infectionsNon-primary care physiciansAcute care visitsUrinary tract infectionFDA black box warningPrimary care physiciansAdministrative claims dataCase mix indexFluoroquinolone prescriptionsPrescribing trendsCare visitsPrescribing ratesTract infectionsOutpatient visits
2019
Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings.
Solotke MT, Ross JS, Shah ND, Karaca-Mandic P, Dhruva SS. Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings. Journal Of Managed Care & Specialty Pharmacy 2019, 25: 1201-1217. PMID: 31663461, PMCID: PMC10397710, DOI: 10.18553/jmcp.2019.25.11.1201.Peer-Reviewed Original ResearchConceptsBlack box warningFDA black box warningBox warningFormulary restrictionsFormulary coverageMean percentageNew black box warningsMain outcome measuresPrecision Health EconomicsNational InstituteOutcomes Research InstituteBlue Cross Blue Shield AssociationHealth care qualityCohort studyBoxed warningUnsafe medicationsDrug therapyStep therapy requirementsMayo ClinicFormulary changeOutcome measuresBlue Shield AssociationJohn Arnold FoundationDrug AdministrationFormulary management
2017
Association between FDA black box warnings and Medicare formulary coverage changes.
Dhruva SS, Karaca-Mandic P, Shah ND, Shaw DL, Ross JS. Association between FDA black box warnings and Medicare formulary coverage changes. The American Journal Of Managed Care 2017, 23: e310-e315. PMID: 29087169.Peer-Reviewed Original ResearchConceptsFDA black box warningBlack box warningNew black box warningsBox warningCardiovascular riskDrug alternativesNew safety informationMajority of drugsFormulary changeRetrospective analysisFormulary coverageFormularyDrugsCapsule formulationSubstantial proportionMedicationsDeathRiskSafety informationFDAYears