Skip to main content

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];