We really need to talk: adapting FDA processes to rapid change.

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY
Food and drug law journal Pub Date : 2013-01-01
Sara Lykken
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引用次数: 0

Abstract

The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in which the definitions and procedures resulting from that past continue to be challenged by new products as market entrants, some in good faith and others not, take actions that create disconnects between actual product and marketing controls and those that consumers might expect. The paper then explores some of the techniques used by other federal agencies that have faced similar challenges in environments characterized by rapid innovation, and draws from this analysis suggestions for improvement of the FDA's warning letter system.

我们真的需要谈谈:调整FDA流程以适应快速变化。
快速发展的现代商业领域对传统的监管范式造成了压力。本文追溯了FDA危机应对监管的历史演变,并提供了一些例子,说明过去产生的定义和程序继续受到新产品作为市场进入者的挑战,有些是出于善意,有些则不是,采取行动,在实际产品和营销控制与消费者可能期望的控制之间造成脱节。然后,本文探讨了在快速创新的环境中面临类似挑战的其他联邦机构所使用的一些技术,并从分析中得出了改进FDA警告信系统的建议。
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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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