2021
Fulfilling the Mandate of the US Food and Drug Administration’s Accelerated Approval Pathway
Gyawali B, Ross JS, Kesselheim AS. Fulfilling the Mandate of the US Food and Drug Administration’s Accelerated Approval Pathway. JAMA Internal Medicine 2021, 181: 1275-1276. PMID: 34254981, DOI: 10.1001/jamainternmed.2021.4604.Commentaries, Editorials and LettersImplementation of 21st Century Cures Act Expanded Access Policies Requirements
Kang S, Chang S, Ross JS, Miller JE. Implementation of 21st Century Cures Act Expanded Access Policies Requirements. Clinical Pharmacology & Therapeutics 2021, 110: 1579-1584. PMID: 34431083, DOI: 10.1002/cpt.2401.Peer-Reviewed Original Research
2020
Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015
MacGregor A, Zhang AD, Wallach JD, Ross JS, Herder M. Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015. JAMA Network Open 2020, 3: e209498. PMID: 32706379, PMCID: PMC7382003, DOI: 10.1001/jamanetworkopen.2020.9498.Peer-Reviewed Original Research
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
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