Food and drug law journal最新文献_第7页

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

Food and drug law journal Pub Date : 2014-01-01

Daniel B Kramer, Yongtian T Tan, Chiaki Sato, Aron S Kesselheim

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

Food and drug law journal Pub Date : 2014-01-01

Julie Ralston Aoki, Shari A Dawkins, Susan K Bishop

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

Food and drug law journal Pub Date : 2014-01-01

Margaret A Hamburg

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

Food and drug law journal Pub Date : 2014-01-01

Lutz-Christian Wolff

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

Food and drug law journal Pub Date : 2014-01-01

Jillian London

{"title":"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.","authors":"Jillian London","doi":"","DOIUrl":"","url":null,"abstract":"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.","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"69 2","pages":"315-42, ii-iii"},"PeriodicalIF":0.2,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32618602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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

Food and drug law journal Pub Date : 2014-01-01

Jeffrey K Shapiro

{"title":"Substantial Equivalence Premarket Review: the Right Approach for Most Medical Devices.","authors":"Jeffrey K Shapiro","doi":"","DOIUrl":"","url":null,"abstract":"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.","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"69 3","pages":"365-97, i"},"PeriodicalIF":0.2,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34706552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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

Food and drug law journal Pub Date : 2014-01-01

Mikyung Kim

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

Food and drug law journal Pub Date : 2014-01-01

Lauren M Azebu

{"title":"The FDA's risk/benefit calculus in the approvals of Qsymia and Belviq: treating an obesity epidemic while avoiding another fen-phen.","authors":"Lauren M Azebu","doi":"","DOIUrl":"","url":null,"abstract":"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.","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"69 1","pages":"87-111, ii-iii"},"PeriodicalIF":0.2,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32296291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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

Food and drug law journal Pub Date : 2014-01-01

Sarah Blankstein

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

Food and drug law journal Pub Date : 2014-01-01

H Weisblatt, Claire Frezza

引用次数: 0