2014
Devices, Drugs, and Difference: Deep Brain Stimulation and the Advent of Personalized Medicine
Fins J. Devices, Drugs, and Difference: Deep Brain Stimulation and the Advent of Personalized Medicine. 2014, 607-620. DOI: 10.1007/978-94-007-4707-4_33.Peer-Reviewed Original ResearchFDA humanitarian device exemptionIntellectual property exchangeHumanitarian Device ExemptionPharmaceutical regulationDevice regulationProperty exchangeTherapeutic misconceptionInvestigative realmsPatient-centered needsDeep brain stimulationAdvent of personalized medicinePersonalized medicineObsessive-compulsive disorderRegulationBrain stimulationInterdisciplinary expertiseFace barriersExemptionMolecular therapeuticsConflictInvestigation toolScope
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 ResearchConceptsIntellectual 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 ResearchConceptsObsessive-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