Lanter Jennifer
Access and Revenue Cycle Department, Ohio State University Medical Center, Columbus, OH 43218-3102, USA.
Dimens Crit Care Nurs. 2007 May-Jun;26(3):117-20. doi: 10.1097/01.DCC.0000267805.49487.33.
New investigational drugs and devices are commonly used in critically ill patients. The development of new drugs and the role of the critical care nurse caring for subjects in clinical trials are crucial to the success of the research process. The purpose of this article is to discuss the Food and Drug Administration's regulatory approval process for significant risk investigational devices.
新型研究性药物和器械常用于危重症患者。新药的研发以及重症护理护士在临床试验中对受试者的护理作用对于研究过程的成功至关重要。本文旨在探讨美国食品药品监督管理局对具有重大风险的研究性器械的监管审批流程。
