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U.S. Department of Health and Human Services

Emergency Preparedness and Response

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Emergency Use Authorization--Archived Information

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats by facilitating the availability of MCMs needed during public health emergencies. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3), 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 (Public Law 108-276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) (Public Law 113-5), which was enacted in March 2013.
 
The EUAs listed below are no longer in effect because they have been terminated.
 
 
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H1N1: Antiviral Disposition Information

Post-H1N1 Public Health Emergency FDA EUA activity specific to Oseltamivir (Tamiflu), Zanamivir (Relenza), and Peramivir

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H1N1: Antiviral Medical Device EUA Information

Post-H1N1 Public Health Emergency FDA EUA Activity Specific to In Vitro Diagnostic Tests

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H1N1 EUA Information

Expired Public Health Emergency Declarations and Terminated EUAs

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