What is an Emergency Use Authorization (EUA) and when is it used?

• A. A mechanism for FDA to allow the use of unapproved products during declared emergencies when no satisfactory alternatives exist
• B. A process to accelerate approval of vaccines
• C. An authorization to export drugs during emergencies
• D. A way to adjust labeling during shortages

Answer: (A)

An Emergency Use Authorization is a tool the FDA uses to make potentially helpful medical products available during a declared public health emergency, even if they haven’t gone through full approval yet. It rests on the idea that in certain urgent situations there aren’t satisfactory approved alternatives, so providing access to a product with support suggesting potential benefit can save lives or reduce harm.

Key idea is that the product is allowed to be used because the emergency conditions create greater urgency and the balance of benefits and risks is considered favorable under the circumstances. The authorization is specifically tied to the emergency, is temporary, and comes with conditions—such as labeling requirements, postmarket monitoring, and restrictions on use—so the situation can be reevaluated as more data become available.

EUAs can cover drugs, vaccines, diagnostics, or medical devices, and they are designed to be revocable if new safety concerns arise or if the emergency ends. A well-known example is the use of certain vaccines and treatments during the COVID-19 pandemic, which were authorized under EUAs to address the urgent public health need while additional data were being collected for full approval.