2013
Error and Bias in the Evaluation of Prescription Opioid Misuse: Should the FDA Regulate Clinical Assessment Tools?
Meltzer E, Hall W, Fins J. Error and Bias in the Evaluation of Prescription Opioid Misuse: Should the FDA Regulate Clinical Assessment Tools? Pain Medicine 2013, 14: 982-987. PMID: 23594383, DOI: 10.1111/pme.12099.Peer-Reviewed Original ResearchMeSH KeywordsAnalgesics, OpioidHumansOpioid-Related DisordersPrescription Drug DiversionPrescription Drug MisuseSubstance-Related DisordersSurveys and QuestionnairesUnited StatesUnited States Food and Drug AdministrationConceptsFood and Drug AdministrationClinical assessment toolScreening toolAssessment toolOpioid-related aberrant behaviorsAberrant medication-related behaviorsOpioid-related risksChronic opioid therapyPrescription opioid misusePredictive of addictionMedication-related behaviorsOpioid therapyPain medicationStandardized questionnaireOpioid misuseIdentified patientsAt-riskDrug AdministrationDiagnose illnessAddictive disordersPatientsAberrant behaviorScreeningComprehensive planAddiction
2012
Challenges to deep brain stimulation: a pragmatic response to ethical, fiscal, and regulatory concerns
Fins J, Dorfman G, Pancrazio J. Challenges to deep brain stimulation: a pragmatic response to ethical, fiscal, and regulatory concerns. Annals Of The New York Academy Of Sciences 2012, 1265: 80-90. PMID: 22823486, PMCID: PMC4030320, DOI: 10.1111/j.1749-6632.2012.06598.x.Peer-Reviewed Original ResearchMeSH KeywordsBiomedical ResearchConflict of InterestDeep Brain StimulationDevice ApprovalGovernment RegulationHumansIntellectual PropertyPublic-Private Sector PartnershipsUnited StatesUnited States Food and Drug AdministrationConceptsIntellectual property exchangePre-market approval processBayh-Dole ActIntellectual property interestsCommon-sense strategiesProperty interestsBayh-DoleRegulatory sphereProperty exchangeManagement of conflictCollege recommendationsApproval processRegulatory concernsPragmatic responseFunded researchPublic-private partnershipInformal mannerExemptionActReformRevisionConflictGovernmentInterest
2011
Misuse Of The FDA’s Humanitarian Device Exemption In Deep Brain Stimulation For Obsessive-Compulsive Disorder
Fins J, Mayberg H, Nuttin B, Kubu C, Galert T, Sturm V, Stoppenbrink K, Merkel R, Schlaepfer T. Misuse Of The FDA’s Humanitarian Device Exemption In Deep Brain Stimulation For Obsessive-Compulsive Disorder. Health Affairs 2011, 30: 302-311. PMID: 21289352, DOI: 10.1377/hlthaff.2010.0157.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicCompassionate Use TrialsDeep Brain StimulationDiffusion of InnovationEquipment and SuppliesHealth Services MisuseHumansObsessive-Compulsive DisorderUnited StatesUnited States Food and Drug AdministrationConceptsObsessive-compulsive disorderHumanitarian Device ExemptionSevere obsessive-compulsive disorderUS Food and Drug AdministrationFDA humanitarian device exemptionNeuropsychiatric disordersFood and Drug AdministrationDeep brain stimulationClinical trialsBrain stimulationDrug AdministrationDisordersPatientsFederal regulationsPatient safeguardsProcedure—isExemption