FDA Guidance on the Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
- File number:
- Issued by:
Guidance Dissemination Office
Biologics Evaluation and Research Center
Center for Devices and Radiation 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 on January 27, 2021
The 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. The FDA is committed to providing timely guidance to support response efforts to this pandemic.
The FDA publishes these guidelines to provide general considerations to help sponsors ensure the safety of trial participants, maintain good clinical practice (GCP) compliance, and minimize risk to trial integrity during the duration of the COVID-19 public health emergency. The appendix to this guidance further explains these general considerations by providing answers to questions the Agency has received about conducting clinical trials during the COVID-19 public health emergency.
You may submit online or written comments on any guide at any time (see 21 CFR 10.115(g)(5))
If you cannot submit comments online, please send your written comments to:
Food and drug administration
5630 Fisherman’s Lane, Room 1061
Rockville, MD 20852
All written comments should be identified by the file number of this document: FDA-2020-D-1106-0002.