Committee Staff Report to the Chairman and Ranking Member: Review of the FDA's Approval Process for the Vagus Nerve Stimulation Therapy System for Treatment-resistant Depression, Volume 4
U.S. Government Printing Office, Jan 1, 2006 - Depression, Mental - 386 pages
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12 months acute phase additional agency amendment antidepressant antidepressant treatments Appendix application approvable letter assessment baseline CDRH Director Center for Devices clinical data clinical study clinical trial Committee Staff comparison control group control study Cyberonics death deficiencies depressive symptoms determine Devices and Radiological DGRND diathermy disorder documents Drug Administration dysphagia Dyspnea efficacy electroconvulsive therapy endpoint epilepsy FDA approval FDA's follow-up Food and Drug HRSD IDS-SR improvement investigational issues labeling least burdensome linear regression long-term phase Magnet manufacturing medical devices Neurological Devices observational patients pivotal D-02 placebo effect PMA supplement postapproval programming propensity score Pulse Radiological Health randomized reasonable assurance regulations reported request response rates review team risks safety and effectiveness score Section seizures sham sleep apnea sponsor statistically significant submission submitted suicide System for TRD team leader treatment-resistant depression Vagus Nerve Stimulation VNS Therapy System worsening depression