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The Role of FDA CDER Statisticians in Response Efforts to the COVID-19 Pandemic
Statistics in Biopharmaceutical Research ( IF 1.8 ) Pub Date : 2020-12-23 , DOI: 10.1080/19466315.2020.1841024
Sylva H. Collins 1 , Dionne Price 2 , Laura Lee Johnson 3
Affiliation  

Abstract–The current outbreak of respiratory disease is caused by a novel coronavirus. The virus has been named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the disease it causes has been named coronavirus disease 2019 (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19, effective January 27, 2020, and mobilized the Operating Divisions of HHS1. In addition, on March 13, 2020, the President of the United States declared a national emergency in response to COVID-192. The Food and Drug Administration (FDA), an HHS agency, plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the COVID-19 pandemic. For example, FDA is committed to providing timely guidance to support responses to this pandemic. The Office of Biostatistics (OB) in the Center for Drug Evaluation and Research (CDER) has worked on numerous Guidances for Industry related to COVID-19, including four of particular interest to statisticians.



中文翻译:

FDA CDER 统计学家在应对 COVID-19 大流行中的作用

摘要-当前爆发的呼吸道疾病是由一种新型冠状病毒引起的。该病毒已被命名为严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2),其引起的疾病已被命名为 2019 年冠状病毒病 (COVID-19)。2020 年 1 月 31 日,卫生与公众服务部 (HHS) 发布了与 COVID-19 相关的突发公共卫生事件声明,自 2020 年 1 月 27 日起生效,并动员了 HHS1 的运营部门。此外,2020 年 3 月 13 日,美国总统宣布全国进入紧急状态以应对 COVID-192。美国食品和药物管理局 (FDA) 是 HHS 的一个机构,在保护美国免受新发传染病(包括 COVID-19 大流行)等威胁方面发挥着关键作用。例如,FDA 致力于提供及时的指导,以支持应对这一流行病。药物评估和研究中心 (CDER) 的生物统计学办公室 (OB) 制定了许多与 COVID-19 相关的行业指南,其中包括统计学家特别感兴趣的四项指南。

更新日期:2020-12-23
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