期刊
JOURNAL OF NANOPARTICLE RESEARCH
卷 13, 期 4, 页码 1401-1417出版社
SPRINGER
DOI: 10.1007/s11051-011-0253-y
关键词
Applied philosophy; Chemical action; Convergent technology; Device classification; Drug classification; Food and drug law; Physicalism; Nanotechnology; Nanoparticles; Regulation of nanotechnology; Governance
资金
- National Science Foundation (NSF) [0608791]
- Divn Of Social and Economic Sciences
- Direct For Social, Behav & Economic Scie [0608791] Funding Source: National Science Foundation
Nanotechnology, as with many technologies before it, places a strain on existing legislation and poses a challenge to all administrative agencies tasked with regulating technology-based products. It is easy to see how statutory schemes become outdated, as our ability to understand and affect the world progresses. In this article, we address the regulatory problems that nanotechnology posses for the Food and Drug Administration's (FDA) classification structure for drugs and devices. The last major modification to these terms was in 1976, with the enactment of the Medical Device Amendments. There are serious practical differences for a classification as a drug or device in terms of time to market and research. Drugs are classified, primarily, as acting by chemical action. We lay out some legal, philosophic, and scientific tools that serve to provide a useful, as well as legally and scientifically faithful, distinction between drugs and devices for the purpose of regulatory classification. These issues we raise are worth the consideration of anyone who is interested in the regulation of nano-products or other novel technologies.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据