2024
Temporary FDA Advisory Committee Members, Recommendations, and Agency Actions, 2017-2021
Chaudhry N, Zhang A, Schwartz J, Ramachandran R, Ross J. Temporary FDA Advisory Committee Members, Recommendations, and Agency Actions, 2017-2021. JAMA Network Open 2024, 7: e2436789. PMID: 39352702, PMCID: PMC11445682, DOI: 10.1001/jamanetworkopen.2024.36789.Peer-Reviewed Original ResearchMeSH KeywordsAdvisory CommitteesCommittee MembershipHumansUnited StatesUnited States Food and Drug AdministrationPremarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies
Mooghali M, Wallach J, Ross J, Ramachandran R. Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies. JAMA Network Open 2024, 7: e2430486. PMID: 39190303, PMCID: PMC11350476, DOI: 10.1001/jamanetworkopen.2024.30486.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkersClinical Trials as TopicCross-Sectional StudiesDrug ApprovalEndpoint DeterminationHumansProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug AdministrationConceptsFood and Drug Administration tableFood and Drug AdministrationSurrogate end pointsSurrogate markerPostmarketing studiesEnd pointsTraditional approvalCross-sectional studyClinical benefitAccelerated approvalTherapy designClinically significant end pointsReview of therapeuticsPrimary end pointUS Food and Drug AdministrationTrial end pointsSignificant end pointsPostmarketing requirementsPreliminary clinical evidenceApproval pathwayPivotal trialsClinical evidenceBreakthrough therapiesDrug AdministrationTherapyPremarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals
Mooghali M, Mohammad A, Wallach J, Mitchell A, Ross J, Ramachandran R. Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals. JAMA Network Open 2024, 7: e249233. PMID: 38691363, PMCID: PMC11063797, DOI: 10.1001/jamanetworkopen.2024.9233.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic AgentsDrug ApprovalHumansMedical OncologyNeoplasmsProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug AdministrationUS FDA breakthrough therapy designation and consumer drug advertising: a recipe for confusion
Patel N, Mohammad A, Ross J, Ramachandran R. US FDA breakthrough therapy designation and consumer drug advertising: a recipe for confusion. The BMJ 2024, 384: e076138. PMID: 38383007, DOI: 10.1136/bmj-2023-076138.Peer-Reviewed Original ResearchMeSH KeywordsAdvertisingConfusionDrug ApprovalDrug IndustryDrug PrescriptionsHumansUnited StatesUnited States Food and Drug Administration
2023
Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics
Wong A, Miller J, Mooghali M, Ramachandran R, Ross J, Wallach J. Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics. JAMA 2023, 330: 2392-2394. PMID: 38079163, PMCID: PMC10714278, DOI: 10.1001/jama.2023.21958.Peer-Reviewed Original ResearchClinical Trials as TopicDemographyDiffusion of InnovationDrug ApprovalHumansMedical OncologyNeoplasmsTime FactorsUnited StatesUnited States Food and Drug AdministrationEnsuring Public Trust in an Empowered FDA
Ross J, Berg K, Ramachandran R. Ensuring Public Trust in an Empowered FDA. New England Journal Of Medicine 2023, 388: 1249-1251. PMID: 37017494, DOI: 10.1056/nejmp2300438.Peer-Reviewed Original Research