2017
Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010
Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA 2017, 317: 1854-1863. PMID: 28492899, PMCID: PMC5815036, DOI: 10.1001/jama.2017.5150.Peer-Reviewed Original ResearchConceptsNovel therapeuticsSafety eventsAccelerated approvalTherapeutic characteristicsUS FoodDrug AdministrationFDA approvalInitial regulatory approvalClinician decision makingNew safety risksMedian followCohort studyMedian timeMultivariable analysisBoxed warningDrug classesMAIN OUTCOMEClinical practicePostmarket periodPsychiatric diseasesPriority reviewTherapeutic areasOrphan statusPsychiatric therapeuticsBiologics
2010
Responding to an FDA Warning — Geographic Variation in the Use of Rosiglitazone
Shah ND, Montori VM, Krumholz HM, Tu K, Alexander GC, Jackevicius CA. Responding to an FDA Warning — Geographic Variation in the Use of Rosiglitazone. New England Journal Of Medicine 2010, 363: 2081-2084. PMID: 21083379, DOI: 10.1056/nejmp1011042.Peer-Reviewed Original Research