Current Emergency Use Authorizations
December 6th, 2018The 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
Current EUAs
The tables below provide information on current EUAs:
- Anthrax: Doxycycline Mass Dispensing EUA Information and National Postal Model Anthrax EUA Information
- Ebola Virus EUA Information
- Enterovirus D68 (EV-D68) EUA Information
- French Freeze Dried Plasma Information
- H7N9 Influenza EUA Information
- Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information
- Nerve Agent EUA Information
- Zika Virus EUA Information