2022
New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence
Moneer O, Brown BL, Avorn J, Darrow JJ, Mitra-Majumdar M, Joyce KW, Ross M, Pham C, Kesselheim AS. New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence. Drug Safety 2022, 45: 305-318. PMID: 35182362, DOI: 10.1007/s40264-022-01152-9.Peer-Reviewed Original ResearchMeSH KeywordsConsumer Product SafetyDrug ApprovalHumansPharmaceutical PreparationsProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug Administration
2021
Characteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020
Moneer O, Lee CC, Avorn J, Kesselheim AS. Characteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020. JAMA Network Open 2021, 4: e218530. PMID: 33929526, PMCID: PMC8087952, DOI: 10.1001/jamanetworkopen.2021.8530.Peer-Reviewed Original ResearchMeSH KeywordsCross-Sectional StudiesDrug ApprovalDrug IndustryDrug MonitoringHumansProduct Surveillance, PostmarketingResearchSocial Control, FormalUnited StatesUnited States Food and Drug AdministrationVaccines
2020
An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19
Kesselheim AS, Darrow JJ, Kulldorff M, Brown BL, Mitra-Majumdar M, Lee CC, Moneer O, Avorn J. An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19. Health Affairs 2020, 40: 25-32. PMID: 33211535, DOI: 10.1377/hlthaff.2020.01620.Peer-Reviewed Original ResearchMeSH KeywordsCenters for Disease Control and Prevention, U.S.COVID-19COVID-19 VaccinesDrug ApprovalHumansImmunizationPatient SafetyPharmaceutical PreparationsRisk AssessmentSARS-CoV-2United StatesUnited States Food and Drug AdministrationConceptsNew vaccinesVaccine Adverse Event Reporting SystemFDA Vaccine Adverse Event Reporting SystemVaccine Safety DatalinkAdverse Event Reporting SystemEmergency use authorizationCoronavirus disease 2019Assessment of vaccinesEvent Reporting SystemImmune system responseAdverse eventsPivotal trialsVaccine evaluationSurrogate markerSurrogate outcomesDisease 2019Vaccine availabilityDrug AdministrationVaccine developmentVaccineDisease controlSafety surveillanceCOVID-19One-thirdReporting system