2019
Population Impact of Generic Valsartan Recall
Jackevicius CA, Krumholz HM, Chong A, Koh M, Ozaki AF, Austin PC, Udell JA, Ko DT. Population Impact of Generic Valsartan Recall. Circulation 2019, 141: 411-413. PMID: 31707798, DOI: 10.1161/circulationaha.119.044494.Peer-Reviewed Original ResearchConceptsNational Ambulatory Care Reporting System databaseEmergency department visitsRegistered Persons DatabaseOntario Registered Persons DatabaseReporting System databaseHealth care systemDrug recallsSegmented regression analysisBaseline comorbiditiesOral medicationsDepartment visitsHospital admissionMedication useClinical outcomesDischarge diagnosisVital statusChronic conditionsHealthcare databasesHealth CanadaCare systemCanadian InstituteHealth informationPopulation impactPatientsRegression analysis
2012
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies
Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies. New England Journal Of Medicine 2012, 366: 2284-2293. PMID: 22591257, PMCID: PMC3504361, DOI: 10.1056/nejmsa1200223.Peer-Reviewed Original ResearchConceptsNovel therapeutic agentsEuropean Medicines AgencyHealth CanadaTherapeutic agentsNew therapeutic agentsMedian lengthTherapeutic comparisonsDrug AdministrationMedicines AgencyNew drug applicationsPrescription Drug User Fee ActNovel therapeuticsDrug applicationFDAUnique agentUnited StatesTotal review timeFirst reviewRegulatory agenciesReview timeDaysAgentsReviewRegulatory reviewVast majority