Emergency Use Authorization — What It Means in Clinical Trials
Plain English Definition
Emergency Use Authorization (EUA) is a mechanism the FDA uses to allow unapproved medical products — drugs, vaccines, or tests — to be used during a public health emergency. An EUA requires less evidence than full approval but still demands sufficient data showing the benefits outweigh the risks. EUAs became widely known during the COVID-19 pandemic.
Why It Matters
A drug under EUA is available outside of clinical trials but has not completed the full approval process. If you received a treatment under EUA, additional data is still being collected about its long-term safety and effectiveness.
Example
During COVID-19: "The Pfizer-BioNTech COVID-19 vaccine received Emergency Use Authorization in December 2020, followed by full approval in August 2021."
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