Substantial Equivalence Premarket Review: the Right Approach for Most Medical Devices [0.03%]
大多数医疗器械的市场准入审查应采用实质等同原则
Jeffrey K Shapiro
Jeffrey K Shapiro
The Food and Drug Administration (FDA)'s 510(k) program based upon substantial equivalence review is by far the dominant pathway to market among medical devices requiring premarket review. Substantial equivalence review has been much critic...
Who to Sue and Where in ANDA Litigation: Personal Jurisdiction Post-Daimler [0.03%]
后Daimler判决下ANDA诉讼的管辖权问题分析：可以起诉谁？在哪里起诉？
H Weisblatt,Claire Frezza
H Weisblatt
Historically, courts have afforded patent holders broad discretion to choose where to sue Abbreviated New Drug Application (ANDA) filers. Patent holders' assertions of jurisdiction have typically rested on general personal jurisdiction theo...
Margaret A Hamburg
Margaret A Hamburg
The Right to Try: An Overview of Efforts to Obtain Expedited Access to Unapproved Treatment for the Terminally Ill [0.03%]
垂死病人获取未获批准治疗的快速通道的尝试权利概述
Alexandra Tsakopoulos,Juyoun Han,Heather Nodler et al.
Alexandra Tsakopoulos et al.
Closing the Door to Lost Earnings Under the National Childhood Vaccine Injury Act of 1986 [0.03%]
1986年国家儿童疫苗受害法案关闭丧失工资索赔之门
Aaron Levin
Aaron Levin
After a wave of lawsuits against vaccine manufacturers hindered the profitability and production of life-saving vaccines, Congress enacted The National Childhood Vaccine Injury Act of 1986. The Act offers an incentive for individuals to get...
Sperm Banking as a Strategy to Reduce Harms Associated with Advancing Paternal Age [0.03%]
精子冻存可减少高龄生育给子女带来的风险策略
William C Hudson
William C Hudson
Medical studies increasingly link paternal age with disorders in offspring. Associated disorders include autism, bipolar disorder, schizophrenia, and ADHD. Banking one's sperm earlier in life, thereby reducing the effective paternal age at ...
Sweet Knowledge: How Declaring Added Sugars Will Help Consumers Make Informed Food Choices [0.03%]
甜知识：为何要标注添加糖帮助消费者明智选择食品？
Sarah P McDonough
Sarah P McDonough
This paper argues that the Food and Drug Administration (FDA) has the authority to require a declaration of "added sugars" on the nutrition label. FDA has relied on scientific evidence from well-respected sources that concluded that "added ...
"Bringing a Butter Knife to a Gun Fight"? Salience, Disclosure, and FDA's Differing Approaches to the Tobacco Use and Obesity Epidemics [0.03%]
“徒手搏枪战”？重视程度、披露与美国食品药品监督管理局迥异的烟草使用和肥胖流行病应对措施
Josef Weimholt
Josef Weimholt
One might expect--given the vastly different look, feel, and function of the ubiquitous (and innocuous) Nutrition Facts panel and the "inflammatory" graphic warning labels for cigarettes--that the statutes establishing such disclosure requi...
Comprehensive Legislative Reform to Protect the Integrity of the 340B Drug Discount Program [0.03%]
关于保护340B药物折扣计划完整性的全面立法改革议案
Lowell M Zeta
Lowell M Zeta
The 40B Drug Discount Program (340B Program) is a federally facilitated program that requires drug manufacturers to provide steep discounts on outpatient prescription drugs to qualifying safety net health care providers. The federal program...
A Legislative Reform for the Food Safety System of China: A Regulatory Paradigm Shift and Collaborative Governance [0.03%]
中国的食品安全法规改革：一场监管范式革命与协作治理
Yonghong Han
Yonghong Han
After describing the historical development of China's food safety system from the perspectives of legislation and administration, this article discusses progress in its food law (The Draft Amendments to Food Safety Law). As a further legis...