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