Revising the Regulation of Stem Cell-Based Therapies: Critical Assessment of Potential Models.

IF 0.3 4区医学 Q4 FOOD SCIENCE & TECHNOLOGY

Food and drug law journal Pub Date : 2015-01-01

Barbara von Tigerstrom

引用次数: 0

Abstract

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 of them, while others urge strict regulation and stronger enforcement. Within the context of this broader debate, this article examines recent attempts in other jurisdictions to craft specific provisions allowing additional flexibility in regulating cell and tissue therapies: Australia's exemption for autologous cell and tissue therapies, and the hospital exemption in Europe's regulation for advanced therapies.

本刊更多论文

修改干细胞疗法的规则:对潜在模型的关键评估。

鉴于干细胞疗法独特的安全性、有效性和质量问题，其监管在许多方面都具有挑战性。与此同时，公众对这些创新疗法的兴趣导致一些人质疑FDA对它们的监管，而另一些人则敦促严格监管和加强执法。在这一广泛辩论的背景下，本文考察了其他司法管辖区最近为制定允许在调节细胞和组织疗法方面具有额外灵活性的具体条款所做的尝试:澳大利亚对自体细胞和组织疗法的豁免，以及欧洲对先进疗法的医院豁免。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Food and drug law journal 医学-食品科技

CiteScore

0.20

自引率

50.00%

发文量

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.