2021
Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration
Egilman A, Wallach JD, Puthumana J, Zhang AD, Schwartz JL, Ross JS. Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration. Journal Of General Internal Medicine 2021, 36: 3281-3284. PMID: 34131876, PMCID: PMC8205312, DOI: 10.1007/s11606-021-06943-x.Peer-Reviewed Original ResearchMeSH KeywordsDrug ApprovalHumansProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug AdministrationVaccinesSpeed, Evidence, and Safety Characteristics of Vaccine Approvals by the US Food and Drug Administration
Puthumana J, Egilman AC, Zhang AD, Schwartz JL, Ross JS. Speed, Evidence, and Safety Characteristics of Vaccine Approvals by the US Food and Drug Administration. JAMA Internal Medicine 2021, 181: 559-560. PMID: 33170923, PMCID: PMC7656319, DOI: 10.1001/jamainternmed.2020.7472.Peer-Reviewed Original ResearchMeSH KeywordsDrug ApprovalHumansUnited StatesUnited States Food and Drug AdministrationVaccine DevelopmentVaccinesDemographic Characteristics of Participants in Trials Essential to US Food and Drug Administration Vaccine Approvals, 2010–2020
Zhang AD, Puthumana J, Egilman AC, Schwartz JL, Ross JS. Demographic Characteristics of Participants in Trials Essential to US Food and Drug Administration Vaccine Approvals, 2010–2020. Journal Of General Internal Medicine 2021, 37: 700-702. PMID: 33660209, PMCID: PMC7928194, DOI: 10.1007/s11606-021-06670-3.Peer-Reviewed Original ResearchMeSH KeywordsDemographyDrug ApprovalHumansUnited StatesUnited States Food and Drug AdministrationVaccinesSpeed Versus Efficacy: Quantifying Potential Tradeoffs in COVID-19 Vaccine Deployment
Paltiel AD, Zheng A, Schwartz JL. Speed Versus Efficacy: Quantifying Potential Tradeoffs in COVID-19 Vaccine Deployment. Annals Of Internal Medicine 2021, 174: m20-7866. PMID: 33395345, PMCID: PMC7787166, DOI: 10.7326/m20-7866.Peer-Reviewed Original ResearchCommunicable Disease ControlCOVID-19COVID-19 VaccinesDisease ProgressionEfficiencyHumansPandemicsPneumonia, ViralSARS-CoV-2Time FactorsUnited StatesUnited States Food and Drug Administration
2020
Evaluating and Deploying Covid-19 Vaccines — The Importance of Transparency, Scientific Integrity, and Public Trust
Schwartz JL. Evaluating and Deploying Covid-19 Vaccines — The Importance of Transparency, Scientific Integrity, and Public Trust. New England Journal Of Medicine 2020, 383: 1703-1705. PMID: 32966716, DOI: 10.1056/nejmp2026393.Peer-Reviewed Original Research
2019
Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008–2015
ZHANG AD, SCHWARTZ JL, ROSS JS. Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008–2015. Milbank Quarterly 2019, 97: 796-819. PMID: 31304643, PMCID: PMC6739629, DOI: 10.1111/1468-0009.12403.Peer-Reviewed Original ResearchMeSH KeywordsAdvisory CommitteesConsensusConsumer Product SafetyDatabases, FactualDevice ApprovalDrug ApprovalUnited StatesUnited States Food and Drug Administration
2016
Fifty Years of Expert Advice — Pharmaceutical Regulation and the Legacy of the Drug Efficacy Study
Schwartz JL. Fifty Years of Expert Advice — Pharmaceutical Regulation and the Legacy of the Drug Efficacy Study. New England Journal Of Medicine 2016, 375: 2015-2017. PMID: 27959733, DOI: 10.1056/nejmp1609763.Peer-Reviewed Original ResearchMeSH KeywordsAdvisory CommitteesConflict of InterestDrug ApprovalDrug IndustryGovernment RegulationHistory, 20th CenturyLegislation, DrugUnited StatesUnited States Food and Drug Administration