Featured Publications
Access to COVID-19 Vaccines in High-, Middle-, and Low-Income Countries Hosting Clinical Trials
Ramachandran R, Ross JS, Miller JE. Access to COVID-19 Vaccines in High-, Middle-, and Low-Income Countries Hosting Clinical Trials. JAMA Network Open 2021, 4: e2134233. PMID: 34792596, PMCID: PMC8603077, DOI: 10.1001/jamanetworkopen.2021.34233.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicCOVID-19COVID-19 VaccinesCross-Sectional StudiesDeveloped CountriesDeveloping CountriesHealth Services AccessibilityHumansIncomePoverty
2018
Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs
Puthumana J, Miller JE, Kim J, Ross JS. Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs. JAMA Network Open 2018, 1: e180283-e180283. PMID: 30646072, PMCID: PMC6324420, DOI: 10.1001/jamanetworkopen.2018.0283.Peer-Reviewed Original ResearchConceptsCompassionate use programInvestigational medicinesFDA approvalNew drug application submissionAccess programExpanded AccessUS FoodAvailable FDA documentsLife-threatening conditionCross-sectional studyEvidence of safetyProtection of patientsUse programClinical trialsMAIN OUTCOMEDrug AdministrationInfectious diseasesDrug accessClinical development periodsFDA documentsApplication submissionPatientsDiseaseApprovalMonths