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 Research
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 Research
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 ResearchConceptsNew 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