Emergency use authorization

Emergency Use Authorization (pronunciation: e-mer-gen-cy use au-tho-ri-za-tion) is a legal means by which the United States Food and Drug Administration (FDA) can approve new medical treatments or procedures during a public health emergency.

Etymology

The term "Emergency Use Authorization" is derived from its function. "Emergency" refers to a situation that requires immediate action. "Use" refers to the application or employment of something. "Authorization" refers to the act of giving official permission for something.

Definition

Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

Related Terms

Public Health Emergency: A declaration by a health authority that a disease or disorder presents a public health threat.
Food and Drug Administration: The federal agency responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods & feed and veterinary products.
COVID-19 pandemic: The ongoing global pandemic of coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).