2020
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
Hwang TJ, Ross JS, Vokinger KN, Kesselheim AS. Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study. The BMJ 2020, 371: m3434. PMID: 33028575, PMCID: PMC7537471, DOI: 10.1136/bmj.m3434.Peer-Reviewed Original ResearchConceptsEuropean Medicines AgencyRetrospective cohort studyTherapeutic valueHigh therapeutic valueNew drugsCohort studyLow therapeutic valueEMA approvalUS FoodDrug AdministrationMedicines AgencyFDA approvalDrugsFDARegulatory approvalApproval programsNew medicinesAssociationGreater proportionApprovalProportionAdministration
2017
Characterizing expanded access and compassionate use programs for experimental drugs
Miller JE, Ross JS, Moch KI, Caplan AL. Characterizing expanded access and compassionate use programs for experimental drugs. BMC Research Notes 2017, 10: 350. PMID: 28754150, PMCID: PMC5534121, DOI: 10.1186/s13104-017-2687-5.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicCompassionate Use TrialsDrugs, InvestigationalHumansProgram Development