2022
Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016
Brown B, Mitra-Majumdar M, Darrow J, Moneer O, Pham C, Avorn J, Kesselheim A. Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016. JAMA Internal Medicine 2022, 182: 1223-1226. PMID: 36190713, PMCID: PMC9531062, DOI: 10.1001/jamainternmed.2022.4226.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 ResearchConceptsUS FoodCross-sectional studyPostmarketing studyPostmarketing requirementsNew vaccinesDrug AdministrationVaccine
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 systemCovid-19, single-sourced diagnostic tests, and innovation policy
Deb C, Moneer O, Price WN. Covid-19, single-sourced diagnostic tests, and innovation policy. Journal Of Law And The Biosciences 2020, 7: lsaa053. PMID: 32908672, PMCID: PMC7454726, DOI: 10.1093/jlb/lsaa053.Commentaries, Editorials and Letters