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U.S. Department of Health and Human Services

Emergency Preparedness and Response

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Emergency Use Authorization

The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), provides key legal authorities to sustain and strengthen national preparedness for public health emergencies. For more information, read here ...

 vaccine

 

During public health emergencies, medical countermeasures (MCMs) may be needed to prevent or treat diseases or conditions caused by chemical, biological, radiological, or nuclear (CBRN) or emerging infectious disease threats, like pandemic influenza.  MCMs are medical products such as drugs, vaccines, diagnostic tests, and other medical equipment and supplies, needed to respond to emergencies involving such threats.



The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.  Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency 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.

Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), which was enacted in March 2013.

GUIDANCE

FDA developed guidance in 2007 explaining FDA's policies for authorizing the emergency use of medical products under section 564 of the FD&C Act. The guidance is intended to inform industry, government agencies, and FDA staff of FDA's general recommendation and procedures for issuance of EUAs.

Note: The statutory authority discussed in the 2007 EUA guidance has been amended by PAHPRA and is in the process of being updated.

 

QUESTIONS AND ANSWERS

In January 2014, FDA issued a question and answer document (PDF, 762K) to respond to questions raised by public health stakeholders about PAHPRA’s amendments to the EUA authority and establishment of new authorities related to the emergency use of MCMs during CBRN emergencies.

 

CURRENT EMERGENCY USE AUTHORIZATIONS

The lists below provide information on current Emergency Use Authorizations.  For a list of previous Emergency Use Authorizations click here.