2023
Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019
Poddar A, Raggio M, Concato J. Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019. Therapeutic Innovation & Regulatory Science 2023, 58: 214-221. PMID: 37926768, PMCID: PMC10764372, DOI: 10.1007/s43441-023-00589-z.Peer-Reviewed Original ResearchConceptsBreakthrough therapy statusTherapy statusInsufficient treatment effectNon-oncology drugsReview of requestsUnmet medical needInadequate study designBreakthrough therapy designationConclusionsThis analysisCommon reasonInvestigational drugsUS FoodMedical needOrphan diseaseStudy designDrug evaluationMarketing approvalCorresponding drugsDrugsApproval statusTreatment effectsDrug developmentFDA processDesignation programStatusUse of Real‐World Evidence in Neuroscience‐Related New Drug and Biologics License Applications for Novel Therapeutics
Bloomfield‐Clagett B, Rahman M, Smith K, Concato J. Use of Real‐World Evidence in Neuroscience‐Related New Drug and Biologics License Applications for Novel Therapeutics. Clinical Pharmacology & Therapeutics 2023, 114: 1002-1005. PMID: 37548904, DOI: 10.1002/cpt.3018.Peer-Reviewed Original Research
2002
Use of Alcohol, Illicit Drugs, and Tobacco Among Characters on Prime-Time Television
Long J, O'Connor P, Gerbner G, Concato J. Use of Alcohol, Illicit Drugs, and Tobacco Among Characters on Prime-Time Television. Substance Use & Addiction Journal 2002, 23: 95-103. DOI: 10.1023/a:1015387222256.Peer-Reviewed Original Research