美国精准肿瘤学检验医学的监管格局——过去5年的视角及未来监管考量
The regulatory landscape of precision oncology laboratory medicine in the United States - Perspective on the past 5 years and considerations for future regulation.
作者信息
Konnick Eric Q
机构信息
Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.
出版信息
Pract Lab Med. 2020 Aug;21:e00172. doi: 10.1016/j.plabm.2020.e00172. Epub 2020 May 30.
Abstract
The regulatory landscape for precision oncology in the United States is complicated, with multiple governmental regulatory agencies with different scopes of jurisdiction. Several regulatory proposals have been introduced since the Food and Drug Administration released a draft guidance to regulate laboratory-developed tests in 2014. Key aspects of the most recent proposals and discussion of central arguments related to the regulation of precision oncology laboratory tests provides insight to stakeholders for future discussions related to regulation of laboratory tests.
摘要
美国精准肿瘤学的监管环境错综复杂，有多个政府监管机构，其管辖范围各不相同。自美国食品药品监督管理局于2014年发布规范实验室开发检测的指南草案以来，已提出了多项监管提案。最新提案的关键要点以及与精准肿瘤学实验室检测监管相关的核心论点讨论，为利益相关者就实验室检测监管的未来讨论提供了见解。
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