Seton Hall University School of Law, USA.
J Law Med Ethics. 2009 Winter;37(4):598-624. doi: 10.1111/j.1748-720X.2009.00434.x.
This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight.
本文运用公共政策、法律和生物伦理学方法，结合多种评估标准，包括经济、社会、安全和技术标准，评估了美国食品和药物管理局（FDA）对药品和医疗器械的监督情况。我们采用综合历史案例研究方法，将标准评估和专家意见征询与现有文献、判例法和法规相结合。然后，我们利用研究结果作为工具，探讨有效监督和监管纳米生物技术的可能性。第一节描述了对人用药品和医疗器械的监督机制，并介绍了当前的纳米技术产品。第二节描述了专家意见征询研究的结果。第三节重点介绍了关键标准，并将其与文献和更广泛的辩论联系起来。最后，我们根据第一至第三节的内容得出了广泛的关于纳米生物技术监督的结论，以便从多个学科和角度提供有用的分析，为讨论适当的 FDA 监督提供指导。
