Do We Need Stronger Sanctions to Ensure Legal Compliance By Pharmaceutical Firms? [0.03%]
我们是否需要更严厉的制裁来确保制药公司的合规性？
Marc A Rodwin
Marc A Rodwin
The increasing number of enforcement lawsuits against pharmaceutical firms and the large size of settlement payments suggest that misconduct is widespread and even risks slipping into the banalities of ordinary business practices. It also r...
The Most Serious Offenses and Penalties Concerning Unsafe Foods under the Food Safety Laws in Bangladesh, India, and Australia: A Critical Analysis [0.03%]
孟加拉国、印度和澳大利亚食品安全法律中关于不安全食品的最严重违规行为及其处罚：批判性分析
S M Solaiman,Abu Noman M Atahar Ali
S M Solaiman
The right to food is an internationally recognized human rignt, which inherently denotes the right to safe food simply because unsafe foods cause different diseases resulting in consumer's disability, organ failure, or even early demise. Fo...
Just a Spoonful of Sugar Will Land You Six Feet Underground: Should the Food and Drug Administration Revoke Added Sugar's GRAS Status? [0.03%]
药监局应撤销对添加糖的公认安全(GRAS)状态的认可吗？
Melissa Marie Card,John Francis Abela
Melissa Marie Card
This article assesses whether added sugar meets FDA's standard to be generally recognized as safe ("GRAS"). If added sugar is not GRAS, then manufacturers are subject to premarket approval prior to using added sugar in their products. This ...
FDA Adverse Event Reporting System: Recruiting Doctors to Make Surveillance a Little Less Passive [0.03%]
美国食品与药物管理局不良事件汇报系统：招募医生让被动监管变得积极一点
Justin M Mann
Justin M Mann
Within the last few decades, a shift has taken place in FDA's approach to drug development, with greater emphasis put on postmarketing data collection and less on the traditional premarketing scheme. The FDA Adverse Event Reporting System (...
Synthetic Biology in the FDA Realm: Toward Productive Oversight Assessment [0.03%]
FDA监管范围内的合成生物学：走向建设性的评估监督
Leili Fatehi,Ralph F Hall
Leili Fatehi
Synthetic biology (SB) is expected to create tremendous opportunities in a wide range of areas, including in foods, therapeutics, and diagnostics subject to regulatory oversight by the United States Food and Drug Administration. At the same...
Revising the Regulation of Stem Cell-Based Therapies: Critical Assessment of Potential Models [0.03%]
修订基于干细胞治疗的监管：潜在模式的关键评估
Barbara von Tigerstrom
Barbara von Tigerstrom
The regulation of stem cell-based therapies is challenging in many respects, given their unique safety, efficacy, and quality issues. At the same time, public interest in these innovative therapies has led some to question FDA's regulation ...
An Unfulfilled Promise: Changes Needed to the Drug Approval Process to Make Personalized Medicine a Reality [0.03%]
任重道远：个性化医疗亟待药物审批制度改革
Margaret Foster Riley
Margaret Foster Riley
The widespread availability of drugs for personalized medicine has been an aspiration since before the human genome was sequenced. Recently, there is renewed interest; personalized medicine is much in the news. Legislation has been consider...
The Limits of FDA's Authority to Regulate Clinical Research Involving High-Throughput DNA Sequencing [0.03%]
FDA监管高通量DNA测序涉及的临床研究的权力范围限制分析
Barbara J Evans
Barbara J Evans
The United States Food and Drug Administration (FDA) recently signaled its interest in subjecting clinical investigations that employ high-throughput gene sequencing, also called next-generation sequencing, to the agency's Part 812 investig...
A New Wave of Vaccines for Non-Communicable Diseases: What Are the Regulatory Challenges? [0.03%]
非传染病疫苗的新一波来袭：监管挑战何在？
Jonathan J Darrow,Aaron S Kesselheim
Jonathan J Darrow
Vaccines represent one of the greatest achievements of medicine, dramatically reducing the incidence of serious or life-threatening infectious diseases and allowing people to live longer, healthier lives. As life expectancy has increased, h...
Remarks of the FDA Commissioner: The Food and Drug Law Institute's 58th Annual Conference [0.03%]
FDA局长的讲话：食品药物协会第58届年会
Stephen Ostroff
Stephen Ostroff