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
2019
Generic Drugs in the United States: Policies to Address Pricing and Competition
Gupta R, Shah ND, Ross JS. Generic Drugs in the United States: Policies to Address Pricing and Competition. Clinical Pharmacology & Therapeutics 2019, 105: 329-337. PMID: 30471089, PMCID: PMC6355356, DOI: 10.1002/cpt.1314.Commentaries, Editorials and LettersConceptsPrice increasesDrug pricesPatent drugsGeneric drugsBrand-name manufacturersGeneric drug applicationsGeneric competitionGeneric versionsPricesPolicy solutionsUnited StatesCompetitionPolicySource of concernPrescription drugsCostPricingMarketAgency policiesPolicymakersCompetitorsPast decadeFDA's roleShortageManufacturers
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
Obstacles to the Adoption of Biosimilars for Chronic Diseases
Hakim A, Ross JS. Obstacles to the Adoption of Biosimilars for Chronic Diseases. JAMA 2017, 317: 2163-2164. PMID: 28459924, DOI: 10.1001/jama.2017.5202.Commentaries, Editorials and Letters
2016
The Rising Price of Naloxone — Risks to Efforts to Stem Overdose Deaths
Gupta R, Shah ND, Ross JS. The Rising Price of Naloxone — Risks to Efforts to Stem Overdose Deaths. New England Journal Of Medicine 2016, 375: 2213-2215. PMID: 27959694, DOI: 10.1056/nejmp1609578.Commentaries, Editorials and Letters
2014
Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison
Zeitoun JD, Lefèvre JH, Downing N, Bergeron H, Ross JS. Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison. PLOS ONE 2014, 9: e109100. PMID: 25333986, PMCID: PMC4204813, DOI: 10.1371/journal.pone.0109100.Peer-Reviewed Original Research