Does science speak clearly and fairly in trade and food safety disputes? The search for an optimal response of WTO adjudication to problematic international standard-making [0.03%]
科学在贸易和食品安全争端中是否说得上话？ WTO裁判对有问题的国际标准制定做出适当回应之探析
Kuei-Jung Ni
Kuei-Jung Ni
Most international health-related standards are voluntary per se. However, the incorporation of international standard-making into WTO agreements like the SPS Agreement has drastically changed the status and effectiveness of the standards. ...
New governance: can user-promulgated certification schemes provide safer, higher quality food? [0.03%]
新的治理模式：用户制定的认证制度能够提供更安全、品质更高的食品吗？
Tacy Katherine Hass
Tacy Katherine Hass
This article explores whether private regulation of food safety may fill in the gaps of statutory food reforms such as the Food Modernization Safety Act. The relatively new economic school of thought labeled "New Governance" centers around ...
The critical path from pump to pancreas: the impact of FDA regulation on the development of a closed-loop diabetes management system [0.03%]
从泵到胰腺的critical路径——美国FDA监管对人工闭环胰岛素输送系统开发的影响分析
Rachel M Sanchez
Rachel M Sanchez
Breakthrough medical tools and technologies are rapidly becoming available in countries across the world, but cannot be purchased in the United States, where these innovative products still await FDA approval. The artificial pancreas is a p...
John B Reiss,Dawn Crowder,Brittany McCabe et al.
John B Reiss et al.
FDA transparency effort continued, including the Secretary's adopting eight measures to improve access to Agency information and activities. A continuing problem was shortages of prescription drugs, which probably was enhanced by increased ...
Genetic gatekeepers: regulating direct-to-consumer genomic services in an era of participatory medicine [0.03%]
基因守门人：在参与式医疗时代规范面向消费者的基因组服务
Jessica Elizabeth Palmer
Jessica Elizabeth Palmer
Should consumers be able to obtain information about their own bodies, even if it has no proven medical value? Direct-to-consumer ("DTC") genomic companies offer consumers two services: generation of the consumer's personal genetic sequence...
Structural precaution: the application of premarket approval schemes in EU food legislation [0.03%]
结构预防措施——欧盟食品法规中上市前审批制度的适用性研究
Bernd M J van der Meulen,Harry J Bremmers,Jo H M Wijnands et al.
Bernd M J van der Meulen et al.
Structural precaution refers to legal requirements by which food products (whether as ingredients, additives, genetically modified or innovative in some other form) are only admitted to the market after authorization by public authorities a...
Comparative effectiveness research panel at the 2012 Advertising & Promotion Conference of the Food & Drug Law Institute [0.03%]
2012年食品和药物法律研究所举办的广告与推广大会上的比较效果研究小组讨论会
Kimberly Westrich,Peter Neumann,Coleen Klasmeier
Kimberly Westrich
Direct-to-consumer genetic testing: learning from the past and looking toward the future [0.03%]
面向消费者的基因检测：借鉴过去，展望未来
Stephanie Bair
Stephanie Bair
A decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to the consumer and purporting to use genetic information to generate individualized health information. ...
John C Monica Jr
John C Monica Jr
Nanotechnology has emerged as an industry with the potential to change many products regulated by the FDA. While the FDA has been regulating products containing nanoscale materials for several years, questions concerning the effectiveness o...
Toward a comprehensive policy on nicotine delivery products and harm reduction [0.03%]
关于尼古丁传送产品和危害减少的全面政策的发展
Jim Solyst
Jim Solyst
Implementation of the Family Smoking Prevention and Tobacco Control Act is resulting in FDA establishing a comprehensive tobacco policy, which includes a scientific evidence based process to characterize tobacco harm reduction products. The...