Pharmacogenomics: history, barriers, and regulatory solutions.

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY
Food and drug law journal Pub Date : 2014-01-01
Sarah Blankstein
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引用次数: 0

Abstract

Pharmacogenomics is the branch of pharmacology which looks at the influence of genetic variation on drug response, connecting particular genetic markers with the effectiveness or safety of a drug. Pharmacogenomic products promise to improve medical treatment, lower health care costs, and make the new drug pipeline for FDA approval more efficient. In the last fifteen years, the FDA has approved pharmacogenomic drugs to treat a variety of cancers, HIV-AIDS, and coronary artery disease. Yet, progress in the field of pharmacogenomics has lagged behind the optimistic predictions of many researchers and policymakers. A lack of clear regulatory guidance dealing with pharmacogenomic products has been a major barrier to progress in the field. The FDA has, however, made some headway. In a series of guidance documents released between 2005 and 2011, the FDA has clarified much of its policy with respect to the development, approval, and labeling of pharmacogenomic products. Despite these efforts, many regulatory questions remain unanswered. This paper highlights a number of these regulatory gaps and provides recommendations to address them in a way which encourages increased development and clinical uptake of pharmacogenomic products.

药物基因组学:历史、障碍和监管解决方案。
药物基因组学是药理学的一个分支,它研究遗传变异对药物反应的影响,将特定的遗传标记与药物的有效性或安全性联系起来。药物基因组学产品有望改善医疗,降低医疗成本,并使新药管道更有效地获得FDA的批准。在过去的15年里,FDA已经批准了药物基因组学药物来治疗各种癌症、艾滋病和冠状动脉疾病。然而,药物基因组学领域的进展落后于许多研究人员和决策者的乐观预测。缺乏关于药物基因组学产品的明确监管指导一直是该领域取得进展的主要障碍。然而,FDA已经取得了一些进展。在2005年至2011年间发布的一系列指导文件中,FDA明确了其关于药物基因组学产品开发、批准和标签的大部分政策。尽管做出了这些努力,但许多监管问题仍未得到解答。本文强调了一些这些监管缺口,并提供了建议,以鼓励增加药物基因组学产品的开发和临床应用。
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
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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