2024
Medical Devices Applying for Outpatient Medicare Supplemental Payments
Moneer O, Johnston J, Rathi V, Ross J, Dhruva S. Medical Devices Applying for Outpatient Medicare Supplemental Payments. JAMA Health Forum 2024, 5: e244016. PMID: 39546305, PMCID: PMC11568453, DOI: 10.1001/jamahealthforum.2024.4016.Peer-Reviewed Original ResearchMeSH KeywordsAmbulatory CareCenters for Medicare and Medicaid Services, U.S.Cross-Sectional StudiesDevice ApprovalEquipment and SuppliesHumansMedicareOutpatientsProspective Payment SystemReimbursement MechanismsUnited StatesUnited States Food and Drug AdministrationConceptsCenters for Medicare & Medicaid ServicesMedicare beneficiariesUS Centers for Medicare & Medicaid ServicesCross-sectional studyCross-sectional analysisPatient demographic characteristicsClinical decision-makingMedicaid ServicesMain OutcomesHispanic patientsClinical evidence requirementsPremarket clinical studyOutpatient settingOutpatient paymentsTraditional pathwaysMedicareSupplemental paymentsFiscal yearTransitional pass-through paymentsReimbursementDemographic dataEffectiveness end pointPathway applicationClinical studiesAuthorization pathwaysDirect 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 evidenceConcordanceEndpointTemporary FDA Advisory Committee Members, Recommendations, and Agency Actions, 2017-2021
Chaudhry N, Zhang A, Schwartz J, Ramachandran R, Ross J. Temporary FDA Advisory Committee Members, Recommendations, and Agency Actions, 2017-2021. JAMA Network Open 2024, 7: e2436789. PMID: 39352702, PMCID: PMC11445682, DOI: 10.1001/jamanetworkopen.2024.36789.Peer-Reviewed Original ResearchMeSH KeywordsAdvisory CommitteesCommittee MembershipHumansUnited StatesUnited States Food and Drug AdministrationPremarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies
Mooghali M, Wallach J, Ross J, Ramachandran R. Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies. JAMA Network Open 2024, 7: e2430486. PMID: 39190303, PMCID: PMC11350476, DOI: 10.1001/jamanetworkopen.2024.30486.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkersClinical Trials as TopicCross-Sectional StudiesDrug ApprovalEndpoint DeterminationHumansProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug AdministrationConceptsFood and Drug Administration tableFood and Drug AdministrationSurrogate end pointsSurrogate markerPostmarketing studiesEnd pointsTraditional approvalCross-sectional studyClinical benefitAccelerated approvalTherapy designClinically significant end pointsReview of therapeuticsPrimary end pointUS Food and Drug AdministrationTrial end pointsSignificant end pointsPostmarketing requirementsPreliminary clinical evidenceApproval pathwayPivotal trialsClinical evidenceBreakthrough therapiesDrug AdministrationTherapyPremarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals
Mooghali M, Mohammad A, Wallach J, Mitchell A, Ross J, Ramachandran R. Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals. JAMA Network Open 2024, 7: e249233. PMID: 38691363, PMCID: PMC11063797, DOI: 10.1001/jamanetworkopen.2024.9233.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsDrug ApprovalHumansMedical OncologyNeoplasmsProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug Administration
2023
Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics
Wong A, Miller J, Mooghali M, Ramachandran R, Ross J, Wallach J. Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics. JAMA 2023, 330: 2392-2394. PMID: 38079163, PMCID: PMC10714278, DOI: 10.1001/jama.2023.21958.Peer-Reviewed Original ResearchClinical Trials as TopicDemographyDiffusion of InnovationDrug ApprovalHumansMedical OncologyNeoplasmsTime FactorsUnited StatesUnited States Food and Drug AdministrationFeasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics
Janda G, Wallach J, Dhodapkar M, Ramachandran R, Ross J. Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics. JAMA Internal Medicine 2023, 183: 1271-1273. PMID: 37782514, PMCID: PMC10546285, DOI: 10.1001/jamainternmed.2023.4073.Peer-Reviewed Original ResearchMeSH KeywordsBiological ProductsDrug ApprovalFeasibility StudiesHumansUnited StatesUnited States Food and Drug AdministrationUnique Device Identifiers for Medical Devices at 10 Years
Dhruva S, Ross J, Wilson N. Unique Device Identifiers for Medical Devices at 10 Years. JAMA Internal Medicine 2023, 183: 1045-1046. PMID: 37603351, DOI: 10.1001/jamainternmed.2023.3572.Commentaries, Editorials and LettersMeSH KeywordsHumansProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug AdministrationApproval of Drugs With Unmet Trial End Points—In Reply
Johnston J, Ross J, Ramachandran R. Approval of Drugs With Unmet Trial End Points—In Reply. JAMA Internal Medicine 2023, 183: 889-890. PMID: 37307009, DOI: 10.1001/jamainternmed.2023.2240.Peer-Reviewed Original ResearchTherapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study
Vokinger K, Glaus C, Kesselheim A, Serra-Burriel M, Ross J, Hwang T. Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study. The BMJ 2023, 382: e074166. PMID: 37407074, PMCID: PMC10320829, DOI: 10.1136/bmj-2022-074166.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsCohort StudiesDrug ApprovalEuropeHumansNeoplasmsPharmaceutical PreparationsRetrospective StudiesUnited StatesUnited States Food and Drug AdministrationConceptsEuropean Medicines AgencyRetrospective cohort studyCohort studyTherapeutic valueSupplemental indicationsIndication approvalsHigh therapeutic valueAvailable treatmentsDrug AdministrationUS FoodMedicines AgencyFDA approvalHealth authoritiesCancer disordersSimilar findingsTherapeutic ratingFirst indicationDrugsIndicationsApprovalFDAPatientsLarge subsetProportionPhysiciansAvailability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022
Mooghali M, Ross J, Kadakia K, Dhruva S. Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022. JAMA Internal Medicine 2023, 183: 735-737. PMID: 37184854, PMCID: PMC10186206, DOI: 10.1001/jamainternmed.2023.0727.Peer-Reviewed Original ResearchMeSH KeywordsDevice ApprovalHumansMedical Device RecallsProduct Surveillance, PostmarketingRisk FactorsUnited StatesUnited States Food and Drug AdministrationExtending the US Food and Drug Administration’s Postmarket Authorities
Lynch H, Sachs R, Lee S, Herder M, Ross J, Ramachandran R. Extending the US Food and Drug Administration’s Postmarket Authorities. JAMA Health Forum 2023, 4: e231313. PMID: 37294583, DOI: 10.1001/jamahealthforum.2023.1313.Commentaries, Editorials and LettersDrug ApprovalFoodHumansPharmaceutical PreparationsUnited StatesUnited States Food and Drug AdministrationUS Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019
Dhodapkar M, Ross J, Ramachandran R. US Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019. JAMA Network Open 2023, 6: e2318889. PMID: 37358857, PMCID: PMC10293905, DOI: 10.1001/jamanetworkopen.2023.18889.Peer-Reviewed Original ResearchMeSH KeywordsBiological FactorsBiological ProductsDrug ApprovalHumansPharmaceutical PreparationsUnited StatesUnited States Food and Drug AdministrationLongitudinal Patterns in Testosterone Prescribing After US FDA Safety Communication in 2014
Sankar A, Everhart A, Jena A, Jeffery M, Ross J, Shah N, Karaca-Mandic P. Longitudinal Patterns in Testosterone Prescribing After US FDA Safety Communication in 2014. The Joint Commission Journal On Quality And Patient Safety 2023, 49: 458-466. PMID: 37380503, DOI: 10.1016/j.jcjq.2023.05.003.Peer-Reviewed Original ResearchMeSH KeywordsAgedHumansHypogonadismMaleMedicareOff-Label UsePractice Patterns, Physicians'TestosteroneUnited StatesUnited States Food and Drug AdministrationConceptsCoronary artery diseaseFDA safety communicationPhysician characteristicsLabel prescribingCare physiciansTestosterone prescribingService administrative claims dataNon-primary care physiciansCertain physician characteristicsDrug Administration (FDA) safety communicationPrimary care physiciansAdministrative claims dataCase mix indexTestosterone therapyArtery diseaseTestosterone prescriptionsPrescribing levelsMean agePrescription trendsTeaching hospitalClaims dataPrescription levelsMedicare feePrescribingUS FoodUS Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021
Johnston J, Ross J, Ramachandran R. US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021. JAMA Internal Medicine 2023, 183: 376-380. PMID: 36780148, PMCID: PMC9926353, DOI: 10.1001/jamainternmed.2022.6444.Peer-Reviewed Original ResearchMeSH KeywordsDrug ApprovalHumansPharmaceutical PreparationsResearch DesignUnited StatesUnited States Food and Drug AdministrationEnsuring Public Trust in an Empowered FDA
Ross J, Berg K, Ramachandran R. Ensuring Public Trust in an Empowered FDA. New England Journal Of Medicine 2023, 388: 1249-1251. PMID: 37017494, DOI: 10.1056/nejmp2300438.Peer-Reviewed Original ResearchUS 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 ResearchMeSH KeywordsCommunicationCross-Sectional StudiesHumansProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug AdministrationConceptsNovel therapeuticsNew therapeuticsUS FoodReviewer disagreementTherapeutic approvalsFDA safety communicationCross-sectional studyBlack box warningPatient populationBox warningDrug AdministrationDrug approvalFDA reviewSafety actionsRegulatory approvalTherapeuticsFDAApprovalMarket approvalFDA reviewersReviewersInstances of disagreementReviewActionAdministrationUse of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls
Kadakia K, Dhruva S, Caraballo C, Ross J, Krumholz H. Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls. JAMA 2023, 329: 136-143. PMID: 36625810, PMCID: PMC9857464, DOI: 10.1001/jama.2022.23279.Peer-Reviewed Original ResearchCross-Sectional StudiesDatabases, FactualDevice ApprovalHumansMedical Device RecallsUnited StatesUnited States Food and Drug Administration
2022
Artificial Intelligence in Breast Cancer Screening
Potnis K, Ross J, Aneja S, Gross C, Richman I. Artificial Intelligence in Breast Cancer Screening. JAMA Internal Medicine 2022, 182: 1306-1312. PMID: 36342705, PMCID: PMC10623674, DOI: 10.1001/jamainternmed.2022.4969.Peer-Reviewed Original ResearchArtificial IntelligenceBreast NeoplasmsDevice ApprovalEarly Detection of CancerFemaleHumansMulticenter Studies as TopicRetrospective StudiesUnited StatesUnited States Food and Drug AdministrationCharacterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study
Dhodapkar MM, Shi X, Ramachandran R, Chen EM, Wallach JD, Ross JS. Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study. The BMJ 2022, 379: e071752. PMID: 36198428, PMCID: PMC9533298, DOI: 10.1136/bmj-2022-071752.Peer-Reviewed Original ResearchMeSH KeywordsAdverse Drug Reaction Reporting SystemsChild, PreschoolCross-Sectional StudiesDrug LabelingDrug-Related Side Effects and Adverse ReactionsHumansUnited StatesUnited States Food and Drug AdministrationConceptsPotential safety signalsSafety signalsSectional studyUS FoodDrug Administration Adverse Event Reporting SystemLiterature searchAdverse Event Reporting SystemSentinel InitiativeDrug Safety CommunicationsEvent Reporting SystemDrug safety signalsAdverse eventsCase seriesCase reportRegulatory actionDrug labelingSignificant associationFDA regulatory actionsComprehensive safety evaluationFAERSFDA