2023
Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study
Mooghali M, Ross J, Kadakia K, Dhruva S. Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study. Medical Devices Evidence And Research 2023, 16: 111-122. PMID: 37229515, PMCID: PMC10204764, DOI: 10.2147/mder.s412802.Peer-Reviewed Original ResearchCross-sectional studyClass I medical deviceClass IHigh-risk medical devicesSerious adverse eventsSafety concernsAdverse eventsMedian numberUS FoodRecalled deviceTherapeutic useDevice recallsHigh-risk devicesDevice useSerious safety concernsMedical device recallsMultiple recallsLife-sustaining devicesDevice assessment
2018
Factors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis
Zeitoun J, Ross JS, Atal I, Vivot A, Downing NS, Baron G, Ravaud P. Factors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis. Clinical Pharmacology & Therapeutics 2018, 104: 1000-1007. PMID: 29377075, DOI: 10.1002/cpt.1038.Peer-Reviewed Original Research
2017
Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study
Larochelle M, Downing NS, Ross JS, David FS. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study. BMJ Open 2017, 7: e014582. PMID: 28179418, PMCID: PMC5306516, DOI: 10.1136/bmjopen-2016-014582.Peer-Reviewed Original ResearchConceptsEuropean Medicines AgencyCohort studyClinical impactRare diseaseHealth CanadaNew therapeuticsLikely clinical impactPotential clinical impactUS patientsAvailable therapiesNovel mechanismDrug AdministrationMedicines AgencyNovel therapeuticsUS approvalNew drugsDrugsFDA submissionsReview outcomesTherapeuticsSafety concernsDiseaseFDAMechanistic noveltyAffected population
2015
Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study
Zeitoun JD, Lefèvre JH, Downing NS, Bergeron H, Ross JS. Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study. Pharmacoepidemiology And Drug Safety 2015, 25: 687-694. PMID: 26554874, DOI: 10.1002/pds.3910.Peer-Reviewed Original ResearchConceptsDear Healthcare Professional CommunicationsEuropean Medicines AgencySafety eventsSafety concernsHealthcare Professional CommunicationsNovel medicinesCentralized authorization procedureEMA websitePostmarket studiesRegulatory reviewPostmarket periodMedicines AgencyWithdrawalSafety communicationMedicineSafety evaluationReviewEfficacy And Safety Concerns Are Important Reasons Why The FDA Requires Multiple Reviews Before Approval Of New Drugs
Ross JS, Dzara K, Downing NS. Efficacy And Safety Concerns Are Important Reasons Why The FDA Requires Multiple Reviews Before Approval Of New Drugs. Health Affairs 2015, 34: 681-688. PMID: 25847652, DOI: 10.1377/hlthaff.2014.1160.Peer-Reviewed Original Research