What is the basis for the Emergency Use Authorization?

The Emergency Use Authorization (EUA) is a mechanism that allows for the use of unapproved medical products or unapproved uses of approved medical products during public health emergencies. This authorization is granted by the Food and Drug Administration (FDA) when certain criteria are met, including the outbreak of an infectious disease or a significant threat to public health.

The core of the EUA is its focus on expediting the availability of diagnostic tests, treatments, and vaccines to address the urgent needs arising from serious health crises. For example, during a pandemic or bioterrorism event, immediate access to effective medical products can save lives, as the usual time-consuming approval processes may delay critical response efforts. Thus, the correct response reflects that the basis for the EUA is fundamentally linked to the recognition and response to public health emergencies, making access to potentially life-saving interventions faster and more efficient.