The Emergency Use Authorization (EUA) is a statutory authority which allows the US Food and Drug Administration (FDA) to help strengthen the nation’s public health protections against chemical, biologic, radiological, or nuclear (CBRN) threats by facilitating the availability and use of medical countermeasures (MCMs – i.e., drugs, biologics, vaccines, diagnostic tests, etc.) during public health emergencies.
The EUA allows for the unapproved use (i.e., off label use) of an approved medical product (drug, biologic, vaccine, or device) or the use of an investigational/unapproved product in order to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.
