Table 2 Legal basis and regulatory evidence for emergency use of remdesivir in the USA
From: The use of remdesivir outside of clinical trials during the COVID-19 pandemic
Emergency use of remdesivir | Legal basis | Regulatory evidence issued by FDA |
|---|---|---|
USA | Section 564 of the FD&C Act amended: -By the Project Bioshield Act of 2004; -By the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017 | • Fact Sheet for Health Care Providers [28]; • Fact sheet for patients and parent/caregivers Spanish [29]; • Frequently asked questions on the emergency use authorization for remdesivir for certain hospitalized COVID-19 patients [30]; |