Emergency Use Authorization

An emergency use authorization (EUA), in the United States is a legal means for the Food and Drug Administration (FDA) to approve new drugs or new indications for previously approved drugs during a declared emergency.[1]

ExamplesEdit

In response to requests from the U.S. Centers for Disease Control and Prevention, on April 27, 2009 the FDA issued Emergency Use Authorizations to make available diagnostic and therapeutic tools to identify and respond to the 2009 swine flu outbreak under certain circumstances. The agency issued these EUAs for the use of certain powerful antiviral drugs, and for the quantitative PCR Swine Flu test.[2]

On April 22, 2013, the FDA issued an EUA for the CDC Human Influenza Virus quantitative PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay. This test is for the presumptive detection of novel influenza A (H7N9) virus.[3]

On June 5, 2013, the FDA issued an emergency use authorization for the CDC Novel Coronavirus 2012 quantitative PCR Assay. This test is for the presumptive detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV), formerly known as Novel Coronavirus 2012 or NCV-2012.[4]

The FDA issued an EUA for CDC test kits for COVID-19 in February, 2020.

ReferencesEdit

External linksEdit

Emergency Use Authorization by the FDA