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 ResearchSpeed, 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 ResearchDemographic 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 AdministrationVaccines
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 Research
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 Research