COVID-19 pandemic

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The updated guidance clarifies two previously suggested methods for obtaining informed consent from a hospitalized patient in isolation. In addition, the guidance includes a new question-and-answer regarding how to obtain informed consent from a prospective trial participant in certain circumstances where the enrollment timeframe is limited and the patient can receive a copy of an informed consent document electronically but cannot sign it electronically or print it out for signature. The guidance also clarifies recommendations on documenting details when using video conferencing for trial visits. The FDA issued an emergency use authorization (EUA) for the third diagnostic test for