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 evidenceConcordanceEndpointModernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process.
Kadakia K, Rathi V, Dhruva S, Ross J, Krumholz H. Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process. Annals Of Internal Medicine 2024 PMID: 39374526, DOI: 10.7326/annals-24-00728.Peer-Reviewed Original Research
2018
Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs
Puthumana J, Miller JE, Kim J, Ross JS. Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs. JAMA Network Open 2018, 1: e180283-e180283. PMID: 30646072, PMCID: PMC6324420, DOI: 10.1001/jamanetworkopen.2018.0283.Peer-Reviewed Original ResearchConceptsCompassionate use programInvestigational medicinesFDA approvalNew drug application submissionAccess programExpanded AccessUS FoodAvailable FDA documentsLife-threatening conditionCross-sectional studyEvidence of safetyProtection of patientsUse programClinical trialsMAIN OUTCOMEDrug AdministrationInfectious diseasesDrug accessClinical development periodsFDA documentsApplication submissionPatientsDiseaseApprovalMonths
2017
The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.
Gupta R, Dhruva SS, Fox ER, Ross JS. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States. Journal Of Managed Care & Specialty Pharmacy 2017, 23: 1066-1076. PMID: 28944731, PMCID: PMC10397719, DOI: 10.18553/jmcp.2017.23.10.1066.Peer-Reviewed Original ResearchConceptsUnapproved Drugs InitiativeClinical evidenceAverage wholesale priceFDA approvalPrescription drugsNew clinical trial evidenceMedian shortage durationClinical trial evidenceNew clinical evidenceDrug shortagesNumber of drugsEvidence of safetyUtah Drug Information ServiceHealth-System PharmacistsUS Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016
Rathi VK, Gadkaree SK, Ross JS, Kozin ED, Sethi RK, Naunheim MR, Puram SV, Gray ST. US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016. Otolaryngology 2017, 157: 608-617. PMID: 28786317, DOI: 10.1177/0194599817721689.Peer-Reviewed Original ResearchConceptsPremarket evidenceClinical evidenceClinical performance dataUS FoodAvailable FDA documentsFDA documentsEvidence of safetyDrug Administration clearanceOne-quarterNonclinical evidenceClinical practiceDrug AdministrationFDA clearanceOne-thirdTwo-thirdsClearanceFDATherapeutic devicesEvidenceSafetyOtolaryngologistsMajorityOtologic