EUA

Emergency Use Authorization (EUA)

An Emergency Use Authorization (EUA) is a mechanism by which the United States Food and Drug Administration (FDA) allows the use of unapproved medical products or unapproved uses of approved medical products during a declared emergency. This authorization is intended to facilitate the availability and use of medical countermeasures, including vaccines, treatments, and diagnostic tests, during public health emergencies.

Overview

The EUA process is designed to ensure that medical products can be used in emergency situations when there are no adequate, approved, and available alternatives. The FDA evaluates the available scientific evidence to determine whether the known and potential benefits of the product outweigh the known and potential risks.

Criteria for Issuance

To issue an EUA, the FDA must determine that:

• There is a serious or life-threatening disease or condition.
• Based on the totality of scientific evidence available, it is reasonable to believe that the product may be effective.
• The known and potential benefits of the product outweigh the known and potential risks.
• There are no adequate, approved, and available alternatives.

Process

The EUA process involves several steps: 1. Submission of a request by the product sponsor. 2. Review of the request by the FDA, including evaluation of scientific data. 3. Issuance of the EUA if the criteria are met. 4. Ongoing monitoring and reporting of the product's safety and effectiveness.

Examples

The EUA mechanism has been used in various public health emergencies, including:

• The H1N1 influenza pandemic in 2009.
• The Ebola virus outbreak in 2014.
• The COVID-19 pandemic, during which multiple vaccines and treatments received EUAs.

Limitations and Revocation

An EUA is not a full approval and is only valid for the duration of the emergency declaration. The FDA can revoke or terminate an EUA if the criteria for issuance are no longer met or if new evidence emerges that changes the risk-benefit analysis.

Related Pages

• United States Food and Drug Administration
• COVID-19 pandemic
• Vaccine
• Public health emergency
• Medical countermeasure

See Also

• H1N1 influenza pandemic
• Ebola virus outbreak
• Vaccine development