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Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation. 确保医疗器械的有效性和安全性:监管方法的跨国比较。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2014-01-01
Daniel B Kramer, Yongtian T Tan, Chiaki Sato, Aron S Kesselheim

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 focus on postmarket surveillance. These markets share broad features such as a heavy reliance on passive adverse event collection, reflected by growing enthusiasm for more active and dynamic mechanisms such as unique device identification. More immediately, US and EU systems might benefit from scheduled, compulsory, and consequential re-examination of select devices, as is done in Japan and China, in order to strengthen post-market protection of patients and bolster public health.

监管机构在权衡新型医疗器械的市场批准时,必须仔细平衡其益处和潜在危害。我们对美国、欧盟、日本和中国的设备监管方法进行了法律和政策审查,重点是上市后监管。这些市场具有广泛的特点,如严重依赖被动不良事件收集,反映在对更主动和动态机制(如唯一设备标识)的日益增长的热情。更直接的是,美国和欧盟系统可能会受益于对选定器械的定期、强制性和相应的重新检查,就像日本和中国所做的那样,以加强对患者的上市后保护并促进公共卫生。
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引用次数: 0
Implementing the IOM's recommendations for reducing sodium in the U.S. food supply: considerations and approaches. 实施美国食品供应中减少钠的IOM建议:考虑和方法。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2014-01-01
Julie Ralston Aoki, Shari A Dawkins, Susan K Bishop

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 foods. Establishing limits on sodium uses would lead to a decrease in sodium intake, which, on average, far exceeds dietary recommendations. This article discusses the historical and regulatory context surrounding the IOM's recommendation, analyzes its potential, offers various strategies for implementing it, and concludes that the IOM's recommendation is likely the best tool currently available to achieve widespread sodium reductions in the food supply.

2010年,医学研究所(IOM)建议食品和药物管理局通过逐步降低加工食品和预制食品中允许的钠含量限制来修改钠的普遍安全状态。限制钠的使用将导致钠摄入量的减少,平均而言,钠摄入量远远超过饮食建议。本文讨论了围绕IOM建议的历史和监管背景,分析了其潜力,提供了实施它的各种策略,并得出结论,IOM的建议可能是目前可获得的实现食品供应中广泛减少钠的最佳工具。
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引用次数: 0
Remarks at the Annual Conference of the Food and Drug Law Institute. 在食品药品法研究所年会上的发言。
IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2014-01-01
Margaret A Hamburg
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引用次数: 0
Chinese Outbound Investments in the Food Sector: Hungry for Much More! 中国对外投资食品行业:渴求更多!
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2014-01-01
Lutz-Christian Wolff

This article analyses in its first part the almost dramatic increase of Chinese outbound investments in recent years with a special focus on the food industry. The second part outlines China's legal framework that has governed Chinese outbound investments over the past decade. In its main part this article explores recent steps to liberalize China's economy and assesses how the dismantling of existing restrictions will impact on Chinese investments overseas. It forecasts rather wide-ranging consequences for the non-Chinese food industry as food enterprises have become highly-sought after targets of Chinese outbound investment activities.

本文第一部分分析了近年来中国对外投资的急剧增长,并特别关注食品行业。第二部分概述了过去10年管理中国对外投资的法律框架。本文的主要部分探讨了中国经济自由化的最新举措,并评估了现有限制的解除将如何影响中国的海外投资。报告预测,由于食品企业已成为中国对外投资活动中备受追捧的目标,这将对非中国食品行业产生相当广泛的影响。
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引用次数: 0
Tragedy, transformation, and triumph: comparing the factors and forces that led to the adoption of the 1860 Adulteration Act in England and the 1906 Pure Food and Drug Act in the United States. 悲剧、转变和胜利:比较导致英国通过1860年《掺假法》和美国通过1906年《纯净食品药品法》的因素和力量。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2014-01-01
Jillian London

The 1860 Adulteration Act in England and the 1906 Pure Food and Drug Act in the United States were two of the earliest pieces of legislation to provide generalized regulation of food and drugs on a national scale. While significant scholarly attention has been given to explaining the factors and forces that led to the passage of each Act independent of the other, few books or articles have directly compared the similar individuals and events that led to the adoption of both Acts. This paper attempts to fill that gap. Through a comparative examination, this paper reveals that four main components were key to the national pure food and drug movements in both countries: individuals who crusaded for national adulteration legislation; tragedies that shocked the public into calling for reform; press and publicity that was willing and able to bring the evils of adulteration to the forefront of the public mind; and a transformation of the social, political, and economic systems, which created atmospheres conducive to reform. This paper aims to shed new light on the 1860 Adulteration Act and the 1906 Pure Food and Drug Act--two acts that derive their importance not just from the effect that they directly had on the regulation of food and drugs but also as some of the earliest examples of western governments coming to recognize the need for national regulation to protect the public from harm and coming to embrace their changing role as spearheads of modern regulatory states.

英国1860年的《掺假法》和美国1906年的《纯净食品和药品法》是最早在全国范围内对食品和药品进行普遍监管的两项立法。虽然学术界对解释导致每项法案独立通过的因素和力量给予了极大的关注,但很少有书籍或文章直接比较导致两项法案通过的类似个人和事件。本文试图填补这一空白。通过比较研究,本文揭示了四个主要组成部分是关键的国家纯食品和药品运动在这两个国家:个人对国家掺假立法;悲剧使公众震惊,要求改革;媒体和公众愿意并有能力将掺假的罪恶带到公众思想的前沿;社会、政治和经济体制的转型,创造了有利于改革的氛围。本文旨在对1860年的《掺假法》和1906年的《纯净食品药品法》进行新的阐释——这两项法案的重要性不仅在于它们对食品和药品监管的直接影响,还在于它们是西方政府最早认识到需要通过国家监管来保护公众免受伤害的例子,并开始接受它们作为现代监管国家先锋的不断变化的角色。
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引用次数: 0
Substantial Equivalence Premarket Review: the Right Approach for Most Medical Devices. 实质等效上市前审查:大多数医疗器械的正确方法。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2014-01-01
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 criticized, but this article concludes that it is a powerful regulatory tool allowing FDA to appropriately ensure that the broad range of moderate risk devices meet the statutory requirement of reasonable assurance of safety and effectiveness. The article examines substantial equivalence review in detail, looking at its historical development, the operative legal framework, the specific decision steps FDA follows to reach a substantial equivalence determination, and the strengths of the system in fostering efficiency, predictability, and adaptability in the premarket review of medical devices. The article rebuts the Institute of Medicine's call to scrap substantial equivalence review, and rebuts another critic's finding that substantial equivalence review results in a disproportionate share of serious recalls. The article suggests that a better public 510(k) database would improve the predictability of substantial equivalence review. The article concludes by calling for targeted reform of a basically sound system rather than wholesale condemnation as critics have suggested.

美国食品和药物管理局(FDA)的510(k)计划基于实质等效审查,是目前需要上市前审查的医疗器械进入市场的主要途径。实质等效性审查受到了很多批评,但本文的结论是,它是一种强大的监管工具,允许FDA适当地确保广泛的中等风险器械满足合理保证安全性和有效性的法定要求。本文详细研究了实质等效性审查,着眼于其历史发展,操作法律框架,FDA为达到实质等效性确定而遵循的具体决策步骤,以及该系统在促进医疗器械上市前审查的效率,可预测性和适应性方面的优势。这篇文章反驳了美国医学研究所(Institute of Medicine)取消实质等同审查的呼吁,并反驳了另一位批评者的发现,即实质等同审查导致严重召回的比例不成比例。本文建议,一个更好的公共510(k)数据库将提高实质等同审查的可预测性。文章最后呼吁对一个基本健全的体系进行有针对性的改革,而不是像批评者建议的那样全盘谴责。
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引用次数: 0
Pharmacogenomics and pharmacologic class effect in drug safety management. 药物基因组学与药理学类效应在药物安全管理中的应用。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2014-01-01
Mikyung Kim

The safety of FDA-approved drugs remains a significant concern for patients and medical practitioners. This paper argues that pharmacogenomics can complement pharmacologic class effects in drug-safety management, and their use can be implemented without excessive costs or other impracticalities. Section I of this paper introduces key data, concepts and terms; Section II discusses the phenomenon of pharmacologic class effect as well as the relationship between this phenomenon and the use of pharmacogenomics in both FDA regulation and medical practice; and Section III proposes a means by which simultaneous consideration of pharmacologic class effect and pharmacogenomics can improve the quality of selective risk management.

fda批准的药物的安全性仍然是患者和医疗从业者关注的一个重要问题。本文认为,药物基因组学可以补充药物安全管理中的药理学类效应,并且可以在不增加成本或其他不切实际的情况下实施。本文第一部分介绍了关键数据、概念和术语;第二节讨论了药理学类效应现象,以及这一现象与药物基因组学在FDA监管和医疗实践中的应用之间的关系;第三部分提出了同时考虑药理学类效应和药物基因组学可以提高选择性风险管理质量的方法。
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引用次数: 0
The FDA's risk/benefit calculus in the approvals of Qsymia and Belviq: treating an obesity epidemic while avoiding another fen-phen. FDA批准Qsymia和Belviq的风险/收益计算:在治疗肥胖症流行的同时避免另一种芬-芬。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2014-01-01
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 approve any anti-obesity drugs, despite the magnitude of the epidemic. Some have argued that these public embarrassments have led the FDA to overestimate the risks and underestimate the benefits when deciding whether to approve new anti-obesity drugs. On June 27, 2012, the FDA approved Belviq for chronic weight management, making it the first anti-obesity drug approved by the FDA in thirteen years. Less than one month later, the FDA approved Qsymia for the treatment of obesity. Both drugs had been denied FDA approval less than two years earlier. In this paper, I will first review the obesity crisis and discuss the high-profile market withdrawals of fenfluramine, dexfenfluramine, and sibutramine. Second, I will explain the FDA's drug approval process with a focus on the FDA's risk/benefit calculus. Third, I will compare the FDA's risk/benefit analysis for Qsymia and Belviq in 2010 with the agency's risk/benefit analysis in 2012 to determine what caused the agency to grant approval in 2012 while denying it in 2010. Finally, I will analyze what these drug approvals may mean for the future of other anti-obesity drugs.

随着美国肥胖率的持续上升,医生和患者都要求更多安全有效的药物治疗选择。然而,在芬-芬/Redux和西布曲明失败之后,FDA一直在犹豫是否批准任何抗肥胖药物,尽管这种流行病的规模很大。一些人认为,这些公开的尴尬导致FDA在决定是否批准新的抗肥胖药物时高估了风险,低估了益处。2012年6月27日,FDA批准Belviq用于慢性体重管理,使其成为13年来FDA批准的第一种抗肥胖药物。不到一个月后,FDA批准Qsymia用于治疗肥胖症。不到两年前,这两种药物都被FDA拒绝批准。在本文中,我将首先回顾肥胖危机,并讨论芬氟拉明,右芬氟拉明和西布曲明的高调市场撤回。其次,我将解释FDA的药物批准过程,重点是FDA的风险/收益计算。第三,我将比较FDA 2010年对Qsymia和Belviq的风险/效益分析与该机构2012年的风险/效益分析,以确定导致该机构在2012年批准而在2010年拒绝批准的原因。最后,我将分析这些药物的批准对其他抗肥胖药物的未来意味着什么。
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引用次数: 0
Pharmacogenomics: history, barriers, and regulatory solutions. 药物基因组学:历史、障碍和监管解决方案。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2014-01-01
Sarah Blankstein

Pharmacogenomics is the branch of pharmacology which looks at the influence of genetic variation on drug response, connecting particular genetic markers with the effectiveness or safety of a drug. Pharmacogenomic products promise to improve medical treatment, lower health care costs, and make the new drug pipeline for FDA approval more efficient. In the last fifteen years, the FDA has approved pharmacogenomic drugs to treat a variety of cancers, HIV-AIDS, and coronary artery disease. Yet, progress in the field of pharmacogenomics has lagged behind the optimistic predictions of many researchers and policymakers. A lack of clear regulatory guidance dealing with pharmacogenomic products has been a major barrier to progress in the field. The FDA has, however, made some headway. In a series of guidance documents released between 2005 and 2011, the FDA has clarified much of its policy with respect to the development, approval, and labeling of pharmacogenomic products. Despite these efforts, many regulatory questions remain unanswered. This paper highlights a number of these regulatory gaps and provides recommendations to address them in a way which encourages increased development and clinical uptake of pharmacogenomic products.

药物基因组学是药理学的一个分支,它研究遗传变异对药物反应的影响,将特定的遗传标记与药物的有效性或安全性联系起来。药物基因组学产品有望改善医疗,降低医疗成本,并使新药管道更有效地获得FDA的批准。在过去的15年里,FDA已经批准了药物基因组学药物来治疗各种癌症、艾滋病和冠状动脉疾病。然而,药物基因组学领域的进展落后于许多研究人员和决策者的乐观预测。缺乏关于药物基因组学产品的明确监管指导一直是该领域取得进展的主要障碍。然而,FDA已经取得了一些进展。在2005年至2011年间发布的一系列指导文件中,FDA明确了其关于药物基因组学产品开发、批准和标签的大部分政策。尽管做出了这些努力,但许多监管问题仍未得到解答。本文强调了一些这些监管缺口,并提供了建议,以鼓励增加药物基因组学产品的开发和临床应用。
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引用次数: 0
Who to Sue and Where in ANDA Litigation: Personal Jurisdiction Post-Daimler. ANDA诉讼中的诉讼对象和诉讼地点:后戴姆勒时代的属人管辖权。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2014-01-01
H Weisblatt, Claire Frezza

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 theories, frequently based on an ANDA filers' conduct within the state, including sales, submission to previous lawsuits, and assignments of agents to accept service of process. Consequently, manyANDA cases have taken place in the Districts of Delaware or New Jersey, or where the patent holder is incorporated, despite the ANDA filer's incorporation in a different state. However, since the Supreme Court's decision in Daimler AG v. Bauman, options for the exercise of personal jurisdiction over ANDA filers have narrowed. This article examines what Daimler means for future ANDA filers, and highlights how many patent holders have failed to take this change into account.

从历史上看,法院给予专利持有人广泛的自由裁量权,以选择在何处起诉简略新药申请(ANDA)申请人。专利持有人的管辖权主张通常基于一般属人管辖权理论,通常基于ANDA申请人在州内的行为,包括销售,提交以前的诉讼,以及委托代理人接受程序服务。因此,许多ANDA案件发生在特拉华州或新泽西州,或者专利持有人的注册地,尽管ANDA申报者的注册地在不同的州。然而,自从最高法院在戴姆勒公司诉鲍曼案中作出裁决以来,对ANDA申报人行使个人管辖权的选择已经缩小。本文探讨了戴姆勒对未来的ANDA申报者意味着什么,并强调了有多少专利持有人未能考虑到这一变化。
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引用次数: 0
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Food and drug law journal
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