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 ResearchConceptsUS FoodCross-sectional studyNovel therapeutic agentsDrug AdministrationTherapeutic agentsFrequency of disagreementApprovalAdministration
2018
Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval
Shaw DL, Dhruva SS, Ross JS. Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval. Journal Of Managed Care & Specialty Pharmacy 2018, 24: 10.18553/jmcp.2018.24.12.1230. PMID: 30479199, PMCID: PMC10397592, DOI: 10.18553/jmcp.2018.24.12.1230.Peer-Reviewed Original ResearchConceptsNovel therapeutic agentsPrescription drug plansOrphan drug statusFDA approvalYear of approvalTherapeutic agentsNovel therapeuticsPrior authorizationNovel therapiesPriority reviewStep therapyMedicare prescription drug plansDrug plansDrug coverageNational InstituteDrug statusPart D prescription drug benefitMedicaid ServicesDrug characteristicsTherapeutic areasCross-sectional studyDrug benefit coverageHealth insurance payerBlue Cross Blue Shield AssociationPrescription drug benefit
2014
Publication of Pivotal Efficacy Trials for Novel Therapeutic Agents Approved Between 2005 and 2011: A Cross-sectional Study
Smithy JW, Downing NS, Ross JS. Publication of Pivotal Efficacy Trials for Novel Therapeutic Agents Approved Between 2005 and 2011: A Cross-sectional Study. JAMA Internal Medicine 2014, 174: 1518-1520. PMID: 25070357, PMCID: PMC4221247, DOI: 10.1001/jamainternmed.2014.3438.Peer-Reviewed Original ResearchClinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. JAMA 2014, 311: 368-377. PMID: 24449315, PMCID: PMC4144867, DOI: 10.1001/jama.2013.282034.Peer-Reviewed Original ResearchConceptsPivotal efficacy trialsNovel therapeutic agentsClinical trial evidencePivotal trialsEfficacy trialsTherapeutic agentsEnd pointTrial evidenceMedian numberAvailable FDA documentsSingle pivotal trialTrial end pointsSurrogate end pointsNumber of patientsLength of treatmentCross-sectional analysisPrimary outcomeClinical outcomesTrial completion ratesClinical benefitPlacebo comparatorSurrogate outcomesMAIN OUTCOMEDrug AdministrationUS Food
2012
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies
Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies. New England Journal Of Medicine 2012, 366: 2284-2293. PMID: 22591257, PMCID: PMC3504361, DOI: 10.1056/nejmsa1200223.Peer-Reviewed Original ResearchConceptsNovel therapeutic agentsEuropean Medicines AgencyHealth CanadaTherapeutic agentsNew therapeutic agentsMedian lengthTherapeutic comparisonsDrug AdministrationMedicines AgencyNew drug applicationsPrescription Drug User Fee ActNovel therapeuticsDrug applicationFDAUnique agentUnited StatesTotal review timeFirst reviewRegulatory agenciesReview timeDaysAgentsReviewRegulatory reviewVast majority