Daria Kim
Daria Kim
This article addresses the problem of restricted access to industry-sponsored clinical trial data. In particular, it analyzes the intersection of the competing claims that mandatory disclosure of pharmaceutical test data impedes drug sponso...
The Extent of Harm to the Victim as an Alternative Aggravating Factor for the Conviction of Felony Fraud in the Context of Food-Safety Violations [0.03%]
论食品违法行为中欺诈类犯罪升格处罚情节——兼论被害人损失在刑罚处遇上的意义与功能
Yi-Chen Su
Yi-Chen Su
Finding the intent to defraud or mislead for the conviction of felony fraud could be very tricky in the context of food regulation. As compared to the split among the US federal circuit courts on the interpretation of intent, Taiwan courts ...
Shue Sing Churk
Shue Sing Churk
Harm reduction is an internationally recognized tobacco control strategy. E-cigarettes, being a less harmful alternative to smoking, have the potential to achieve harm reduction. Within this context, this article critiques Hong Kong’s lega...
FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology [0.03%]
美国食品和药物管理局CRISPR-Cas基因编辑技术临床应用监管政策探讨
Evita V Grant
Evita V Grant
Scientists have repurposed an adaptive immune system of single cell organisms to create a new type of gene-editing tool: CRISPR (clustered regularly interspaced short palindromic repeats)-Cas technology. Scientists in China have reported it...
Terry S Coleman
Terry S Coleman
This article is a history of the policy positions and legal interpretations adopted by the Public Health Service (PHS) under the 1902 Biologics Control Act. PHS generally interpreted the scope of the Act narrowly because it lacked authority...
Nigel Barrella
Nigel Barrella
Government-mandated labeling requirements have a long history, and are used extensively by FDA in regulating the industries under its jurisdiction. All such requirements can be characterized as a form of “compelled speech,” opening the do...
You Want a Warning with That? Sugar-Sweetened Beverages, Safety Warnings, and the Constitution [0.03%]
警示过量吗？含糖饮料、安全警示与宪法的问题
Sabrina S Adler,Ian E McLaughlin,Seth E Mermin et al.
Sabrina S Adler et al.
A Spoonful of (Added) Sugar Helps the Constitution Go Down: Curing the Compelled Speech Commercial Speech Doctrine with FDA’s Added Sugars Rule [0.03%]
药到病除——以食药监总局的“添加糖”规则治愈强制言论的商业言论理论
Colleen Smith
Colleen Smith
On May 27, 2016, the Food and Drug Administration (FDA) announced that it was adopting a new rule that requires food manufacturers to list—on the already mandated Nutrition Facts label—how many grams of sugar have been added to a food pro...
Truth, Falsity, and Fraud: Off-Label Drug Settlements and the Future of the Civil False Claims Act [0.03%]
真相、谎言与欺骗：药品说明书以外适应症的和解以及未来民事《虚假索赔法》的发展方向
Joan H Krause
Joan H Krause
The pharmaceutical industry may be losing the battle of public opinion, but it has won important victories in the war over First Amendment commercial speech. In December 2012, the Second Circuit held in United States v. Caronia that the mis...
Erika Lietzan,Julia Post
Erika Lietzan