Diane E Hoffmann,Claire M Fraser,Francis Palumbo et al.
Diane E Hoffmann et al.
The development and marketing of new probiotic products, substances containing live microorganisms that have a beneficial effect on the human body, have dramatically increased over the last few years. This article examines how the Food and ...
Terry S Coleman
Terry S Coleman
The statute and regulations administered by the Food and Drug Administration ("FDA") do not explicitly prohibit the promotion of drugs and medical devices for unapproved uses, yet the government has collected billions of dollars in penaltie...
Ching-Fu Lin
Ching-Fu Lin
In response to an apparent decline in global food safety, numerous public and private regulatory initiatives have emerged to restore public confidence. This trend has been particularly marked by the growing influence of private regulators s...
Annamarie Kempic
Annamarie Kempic
Buckman extended: federal preemption of state fraud-on-the-FDA statutes [0.03%]
布克曼扩展：联邦法律对州级 FDA 诈骗法规的预先否决权
Christine A Gaddis
Christine A Gaddis
A number of states have enacted statutes that provide protection to drug manufacturers in product liability actions. Additionally, several of these states have enacted "fraud-on-the-FDA" statutory provisions, which remove statutory protecti...
The FDA's risk/benefit calculus in the approvals of Qsymia and Belviq: treating an obesity epidemic while avoiding another fen-phen [0.03%]
美国FDA在批准Qsymia和Belviq过程中对风险/效益的计算：在避免成为“芬氟拉明”第二的同时治疗肥胖症这一流行病
Lauren M Azebu
Lauren M Azebu
As obesity rates continue to rise in the United States, both physicians and patients have demanded more safe and effective drug treatment options. However, following the fen-phen/Redux and sibutramine failures, the FDA has been hesitant to ...
Implementing the IOM's recommendations for reducing sodium in the U.S. food supply: considerations and approaches [0.03%]
美国食品供应中减少钠含量的IOM推荐实施方案：考虑因素和策略
Julie Ralston Aoki,Shari A Dawkins,Susan K Bishop
Julie Ralston Aoki
In 2010, the Institute of Medicine (IOM) recommended that the Food and Drug Administration modify the generally recognized as safe status of sodium by setting gradually decreasing limits on sodium amounts allowed in processed and prepared f...
Legal considerations for social media marketing by pharmaceutical industry [0.03%]
药品行业社交媒介市场营销的法律问题考虑因素分析
Y Tony Yang,Brian Chen
Y Tony Yang
Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceu...
Challenging an immediate suspension of a DEA registration: is it time for a new tact? [0.03%]
挑战DEA注册的即时暂停：是时候采取新的策略了吗？
Douglas J Behr
Douglas J Behr
A Drug Enforcement Administration ("DEA") registration is not only a necessity, but also an invaluable commodity for doctors, pharmacists, hospitals and drug wholesalers who prescribe, stock, and distribute controlled substances. While the ...
Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation [0.03%]
确保医疗器械的有效性和安全性：管制方法的跨国比较
Daniel B Kramer,Yongtian T Tan,Chiaki Sato et al.
Daniel B Kramer et al.
Regulatory bodies weighing market approval for novel medical devices must balance the benefits and potential hazards carefully. We performed a legal and policy review of appraoches in the US, EU, Japan, and China to device regulation with a...
Comparative Study
Food and drug law journal. 2014;69(1):1-23, i. DOI: 2014