Food and drug law journal最新文献

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Could State Regulations be the Next Frontier in Preemption Jurisprudence? Drug Compounding as a Case Study. 国家法规会成为优先购买权法理学的下一个前沿吗?药物复合作为案例研究。
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2016-01-01
Nathan A Brown, Eli Tomar
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引用次数: 0
Tracing FTC’s Line on Commercial Speech: What Makes an Ad an Ad and Why Does It Matter? 追踪美国联邦贸易委员会对商业言论的态度:什么使广告成为广告,为什么它很重要?
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2016-01-01
Katie Bond
{"title":"Tracing FTC’s Line on Commercial Speech: What Makes an Ad an Ad and Why Does It Matter?","authors":"Katie Bond","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"71 2","pages":"211-27"},"PeriodicalIF":0.2,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35611874","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
FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology. FDA关于CRISPR-CAS基因编辑技术临床应用的规定。
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2016-01-01
Evita V Grant
{"title":"FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology.","authors":"Evita V Grant","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>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 its use in the genome modification of non-viable human embryos. This has ignited a spirited debate about the moral, ethical, scientific, and social implications of human germline genome engineering. There have also been calls for regulations; however, FDA has yet to formally announce its oversight of clinical applications of CRISPR-Cas systems. This paper reviews FDA regulation of previously controversial biotechnology breakthroughs, recombinant DNA and human cloning. It then shows that FDA is well positioned to regulate CRISPR-Cas clinical applications, due to its legislative mandates, its existing regulatory frameworks for gene therapies and assisted reproductive technologies, and other considerations.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"71 4","pages":"608-33"},"PeriodicalIF":0.2,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35251871","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
Preemption of Non-Federal Restraints on Off-Label Product Communications. 非联邦对标签外产品沟通限制的优先考虑。
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2016-01-01
Jeffrey Chasnow, Geoffrey Levitt
{"title":"Preemption of Non-Federal Restraints on Off-Label Product Communications.","authors":"Jeffrey Chasnow,&nbsp;Geoffrey Levitt","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Evolving First Amendment principles are forcing FDA and other federal regulators of medical products to rethink traditional regulatory approaches to off-label product communications. State regulators, which have actively sought injunctions restricting manufacturer communications to the four-corners of the FDA-approved product label, must additionally abide by federal preemption principles. This article reviews the application of preemption principles to off-label communications and concludes that most, if not all, state-law restraints on off-label communications are preempted by federal law. This finding has important implications for state enforcement initiatives, and puts into question the validity of some elements of existing state-law injunctions.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"71 2","pages":"249-70"},"PeriodicalIF":0.2,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35611872","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
The Law of 180-Day Exclusivity. 180天排他性法则
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2016-01-01
Erika Lietzan, Julia Post
{"title":"The Law of 180-Day Exclusivity.","authors":"Erika Lietzan,&nbsp;Julia Post","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"71 3","pages":"327-400"},"PeriodicalIF":0.2,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35611876","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
A Spoonful of (Added) Sugar Helps the Constitution Go Down: Curing the Compelled Speech Commercial Speech Doctrine with FDA’s Added Sugars Rule. 一勺(添加的)糖有助于宪法下降:用FDA的添加糖规则治愈强迫言论商业言论原则。
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2016-01-01
Colleen Smith
{"title":"A Spoonful of (Added) Sugar Helps the Constitution Go Down: Curing the Compelled Speech Commercial Speech Doctrine with FDA’s Added Sugars Rule.","authors":"Colleen Smith","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>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 product. Many opponents have criticized this “added sugars” rule on First Amendment grounds, arguing that the rule violates the commercial speech rights of food manufacturers. Whether the rule would survive constitutional scrutiny or not is an open question because the compelled commercial speech doctrine is anything but clear. Courts are split over whether Zauderer’s rational basis test, Central Hudson’s intermediate scrutiny, or some combination of the two should apply to a mandated disclosure like FDA’s added sugars rule. This Paper explains that the added sugars rule is unique in the history of mandated nutrition labeling in that the rule is motivated largely by public health concerns and backed by reports that assert that consumers should limit their intake of added sugars. In contrast, correcting and preventing consumer deception has been a major driving force behind the remainder of FDA’s mandated nutrition labeling. Because of this distinct rationale, the added sugars rule does not fit neatly into any currently existing compelled commercial speech test. This Paper uses the added sugars rule to highlight the deficiencies in the existing tests. Finally, this Paper proposes a new compelled commercial speech test that would adequately balance the interest of all of the effected parties: the government, the public, and food manufacturers.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"71 3","pages":"442-81"},"PeriodicalIF":0.2,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35611878","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
You Want a Warning with That? Sugar-Sweetened Beverages, Safety Warnings, and the Constitution. 你想要警告吗?含糖饮料、安全警告和宪法。
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2016-01-01
Sabrina S Adler, Ian E McLaughlin, Seth E Mermin, Reece W Trevor
{"title":"You Want a Warning with That? Sugar-Sweetened Beverages, Safety Warnings, and the Constitution.","authors":"Sabrina S Adler,&nbsp;Ian E McLaughlin,&nbsp;Seth E Mermin,&nbsp;Reece W Trevor","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"71 3","pages":"482-518"},"PeriodicalIF":0.2,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35611879","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
E-cigarette Regulation and Harm Reduction: The Case of Hong Kong. 电子烟规管及减低危害:以香港为例。
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2016-01-01
Shue Sing Churk
{"title":"E-cigarette Regulation and Harm Reduction: The Case of Hong Kong.","authors":"Shue Sing Churk","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>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 legal regime governing e-cigarettes and the proposed prohibition of the product. It is argued that the current law is uncertain and inadequate. Although a reform of laws relating to e-cigarettes is needed, it is argued that banning the product altogether as a means to reducing the harm of tobacco use is unsupported by evidence.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"71 4","pages":"634-57"},"PeriodicalIF":0.2,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35251875","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
Effectively Regulating E-Cigarettes and Their Advertising--And the First Amendment. 有效监管电子烟及其广告——以及第一修正案。
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2015-01-01
Eric N Lindblom
{"title":"Effectively Regulating E-Cigarettes and Their Advertising--And the First Amendment.","authors":"Eric N Lindblom","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"70 1","pages":"55-92"},"PeriodicalIF":0.2,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34107999","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
2nd Annual Eric M. Blumberg Memorial Lecture. 第二届埃里克·布隆伯格纪念讲座。
IF 0.2 4区 医学
Food and drug law journal Pub Date : 2015-01-01
Mark S Brown
{"title":"2nd Annual Eric M. Blumberg Memorial Lecture.","authors":"Mark S Brown","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":"70 1","pages":"93-9"},"PeriodicalIF":0.2,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34108000","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
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