2021
Medicare’s New Device-Coverage Pathway — Breakthrough or Breakdown?
Rathi VK, Johnston JL, Ross JS, Dhruva SS. Medicare’s New Device-Coverage Pathway — Breakthrough or Breakdown? New England Journal Of Medicine 2021, 384: e43. PMID: 33691059, DOI: 10.1056/nejmp2101874.Commentaries, Editorials and Letters
2019
The Bleeding Edge
Pendyal A, Ross JS. The Bleeding Edge. JAMA 2019, 322: 190-192. PMID: 31310276, DOI: 10.1001/jama.2019.8147.Commentaries, Editorials and LettersConceptsRegulatory approval
2018
Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS
Kim J, Ross JS, Kapczynski A. Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS. JAMA 2018, 319: 21-22. PMID: 29117365, DOI: 10.1001/jama.2017.16477.Commentaries, Editorials and Letters
2017
High Costs of FDA Approval for Formerly Unapproved Marketed Drugs
Hakim A, Gupta R, Ross JS. High Costs of FDA Approval for Formerly Unapproved Marketed Drugs. JAMA 2017, 318: 2181-2182. PMID: 29131905, DOI: 10.1001/jama.2017.16481.Commentaries, Editorials and LettersAssociation of the FDA Amendment Act with trial registration, publication, and outcome reporting
Phillips AT, Desai NR, Krumholz HM, Zou CX, Miller JE, Ross JS. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials 2017, 18: 333. PMID: 28720112, PMCID: PMC5516301, DOI: 10.1186/s13063-017-2068-3.Peer-Reviewed Original ResearchConceptsCardiovascular diseaseTRIAL REGISTRATIONFDA approvalNew drugsClinical trial registrationFDA Amendments ActDrug Administration Amendments ActAccessible trial registryClinical trial publicationsTrials RegistryResultsBetween 2005Efficacy trialsFDA reviewersTrial publicationsOutcome reportingMedical literatureReviewer interpretationsTrialsReporting of findingsDiseaseFDA documentsDrugsDiabetesFDAAAReviewers
2015
Characterizing the US FDA's approach to promoting transformative innovation
Downing NS, Krumholz HM, Ross JS, Shah ND. Characterizing the US FDA's approach to promoting transformative innovation. Nature Reviews Drug Discovery 2015, 14: 740-741. PMID: 26435528, DOI: 10.1038/nrd4734.Peer-Reviewed Original ResearchRegulatory review time and post‐market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study
Zeitoun JD, Lefèvre JH, Downing NS, Bergeron H, Ross JS. Regulatory review time and post‐market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study. British Journal Of Clinical Pharmacology 2015, 80: 716-726. PMID: 25808713, PMCID: PMC4594708, DOI: 10.1111/bcp.12643.Peer-Reviewed Original ResearchTrial-Results Reporting and Academic Medical Centers
Zarin DA, Tse T, Ross JS. Trial-Results Reporting and Academic Medical Centers. New England Journal Of Medicine 2015, 372: 2371-2372. PMID: 25992618, DOI: 10.1056/nejmc1505965.Peer-Reviewed Original Research
2014
Rate of asthma trial outcomes reporting on ClinicalTrials.gov and in the published literature
Stockmann C, Ross JS, Sherwin CMT, Reilly CA, McDowell B, Fassl B, Nkoy F, Maloney CG, Spigarelli MG. Rate of asthma trial outcomes reporting on ClinicalTrials.gov and in the published literature. Journal Of Allergy And Clinical Immunology 2014, 134: 1443-1446. PMID: 25441299, PMCID: PMC4261054, DOI: 10.1016/j.jaci.2014.09.019.Peer-Reviewed Original ResearchWithdrawal of Personal Genome Service—Reply
Downing NS, Ross JS. Withdrawal of Personal Genome Service—Reply. JAMA 2014, 311: 2441-2442. PMID: 24938574, DOI: 10.1001/jama.2014.5584.Commentaries, Editorials and LettersGenetic Predisposition to DiseaseGenetic TestingGovernment RegulationHumansMarketing of Health ServicesInnovation, Risk, and Patient Empowerment: The FDA-Mandated Withdrawal of 23andMe’s Personal Genome Service
Downing NS, Ross JS. Innovation, Risk, and Patient Empowerment: The FDA-Mandated Withdrawal of 23andMe’s Personal Genome Service. JAMA 2014, 311: 793-794. PMID: 24474248, DOI: 10.1001/jama.2014.148.Commentaries, Editorials and Letters
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