FDA新冠肺炎公共卫生事件期间药物临床试验执行指南

2020-09-09 美国食品和药品监督管理局 FDA

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergen

中文标题:

FDA新冠肺炎公共卫生事件期间药物临床试验执行指南

英文标题:

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

发布日期:

2020-09-09

简要介绍:

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

Docket Number:
FDA-2020-D-1106
Issued by:
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice

Updated September 21, 2020

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency.

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