COVID-19 的紧急批准：对临床护理和研究中患者义务的影响不断演变。
Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research.
机构信息
University of Pennsylvania, Philadelphia, Pennsylvania (H.F.L.).
New York University, New York, New York (A.B.).
出版信息
Ann Intern Med. 2021 Feb;174(2):256-257. doi: 10.7326/M20-6703. Epub 2020 Nov 3.
Abstract
There currently is debate regarding whether U.S. institutions and clinicians may or should restrict patient access to COVID-19 drugs and vaccines that have been granted emergency use authorization by the U.S. Food and Drug Administration. The authors provide their views on the legal, ethical, and clinical ramifications of such restriction.
摘要
目前，关于美国的机构和临床医生是否可以或应该限制患者获得已获得美国食品和药物管理局紧急使用授权的 COVID-19 药物和疫苗，存在争议。作者就这种限制的法律、伦理和临床后果发表了看法。
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3
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