Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu's "Scout" [0.03%]
crowdsourcing时代医疗设备监管的启示——以Scanadu的“Scout”为例
Colleen Smith
Colleen Smith
Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article ...
Drugs, Devices & Discovery: Using Fee-Shifting to Resolve the Twombly/Iqbal Problem for Parallel Claims Under the FDCA [0.03%]
药物、器械及发现：利用费用转嫁解决FDCA平行主张下的Twombly/Iqbal问题
Cameron T Norris
Cameron T Norris
The Supreme Court's decisions in Twombly and Iqbal ushered in a new federal pleading standard, requiring plaintiffs to state a "plausible" claim to relief before they can access discovery. Plausibility pleading, however, presents a unique b...
Can You Diagnose Me Now? A Proposal to Modify FDA's Regulation of Smartphone Mobile Health Applications with a Pre-Market Notification and Application Database System [0.03%]
药监局应如何监管移动医疗软件应用程序——建议采取市场前通知和应用程序数据库系统模式
Stephen McInerney
Stephen McInerney
Mobile applications provide limitless possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the Food and Drug Administration (...
Embracing 21st Century Information Sharing: Defining a New Paradigm for the Food and Drug Administration's Regulation of Biopharmaceutical Company Communications with Healthcare Professionals [0.03%]
拥抱21世纪的信息共享：美国食品药品监督管理局规范生物制药公司与医疗卫生专业人士交流的新范式的界定
James M Spears,Jeffrey K Francer,Natale A Turner
James M Spears
The Food and Drug Administration (FDA) plays a unique role in protecting the public health and minimizing the risk of the distribution of unsafe or ineffective medicines in the United States. Perhaps equally as important for public health, ...
FDA-EPA Public Health Guidance on Fish Consumption: A Case Study on Informal Interagency Cooperation in "Shared Regulatory Space" [0.03%]
美国食品药品监督管理局和环境保护署关于鱼品消费的公共指导意见——一个“共享监管空间”中非正式跨界合作的案例研究
Mark Holden
Mark Holden
This article is a case study on how administrative agencies interact with each other in cases of shared regulatory jurisdiction. The theoretical literature on the topic of overlapping jurisdiction both (1) makes predictions about how agenci...
Mark S Brown
Mark S Brown
Effectively Regulating E-Cigarettes and Their Advertising--And the First Amendment [0.03%]
有效监管电子烟及其广告——以及《宪法第一修正案》的影响
Eric N Lindblom
Eric N Lindblom
The End of "Patent Medicines"? Thoughts on the Rise of Regulatory Exclusivities [0.03%]
“专利药”的终结？兼论监管排他性的兴起
John R Thomas
John R Thomas
Rebecca Tushnet
Rebecca Tushnet
Lisa Heinzerling
Lisa Heinzerling