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U.S. Department of Health and Human Services


Emergency Use Authorization (EUA)​

  
  
Rationale
  
Bacillus anthracisDeclaration That Circumstances Exist Justifying Authorization of Emergency Use of All Oral Formulations of Doxycycline Accompanied by Emergency Use Information
The Secretary of Health and Human Services (HHS) is declaring that circumstances exist justifying the authorization of emergency use of all oral formulations of doxycycline accompanied by emergency use information subject to the terms of any authorization issued by
the Commissioner of Food and Drugs under section 564(a) of the FD&C Act.
7/23/2013
Middle East respiratory syndrome coronavirus (MERS-CoV)CDC Novel Coronavirus 2012 Real-time RT-PCR Assay
On May 29, 2013 Secretary Kathleen Sebelius determined that Middle East respiratory syndrome coronavirus (MERS-CoV) poses a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad. On the basis of this determination the Secretary declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the Middle East respiratory syndrome coronavirus (MERS-CoV).*
7/5/2013
H7N9 InfluenzaCDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay
On April 19, 2013 Secretary Kathleen Sebelius determined that avian influenza A(H7N9) poses a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad. On the basis of this determination the Secretary declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the avian influenza A(H7N9) virus
4/22/2013
Bacillus anthracisRenewal of Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information
The Secretary of Health and Human Services is renewing her July 20, 2011 declaration of an emergency justifying the authorization of emergency use of all oral formulations of doxycycline accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs under 21 U.S.C.
6/28/2012
Bacillus anthracisRenewal of Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information and Amendment To Include All Oral Formulations of Doxycycline
The Secretary of Health and Human Services is renewing the October 1, 2008 declaration by former Secretary Michael O. Leavitt of an emergency justifying the authorization of emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs under
21 U.S.C. 360bbb–3(a) and amending the declaration to include all oral formulations of doxycyline accompanied by emergency use
information subject to the terms of any authorization issued by the Commissioner of Food and Drugs under 21 U.S.C. 360bbb-3(a).
7/20/2011
Bacillus anthracisRenewal of Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergnecy Use Information
On September 23, 2008, the Secretary of the Department of Homeland Security determined that there is a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents--in this case, Bacillus anthracis.   Pursuant to section 564(b)(2)(B) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(b)(B), and on the basis of such determination, Secretary Sebelius renewed the October 1, 2008 declaration by former Secretary Michael O. Leavitt, which was previously renewed on October 1, 2009, of an emergency justifying the authorization of the emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued under 21 U.S.C. §360bbb-3(a).
10/1/2010
H1N1 Pandemic InfluenzaTermination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices
The Food and Drug Administration (FDA) is issuing this notice, under the Federal Food, Drug, and Cosmetic Act (the act), of the termination of the declarations of emergency justifying Emergency Use Authorizations (EUAs) of certain in vitro diagnostic devices, personal respiratory protection devices, and antiviral products that were issued in response to the public health emergency involving 2009 H1N1 Influenza.
6/23/2010
H1N1 Pandemic InfluenzaRenewal of Determination and Declarations Regarding Emergency Use of Certain In vitro Diagnostic, Antiviral, and Personal Respiratory Products Accompanied by Emergency Use Information
The Acting Secretary declared emergencies justifying the authorization of emergency use of certain in vitro diagnostic, antiviral, and personal respiratory protection products accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs (Commissioner) under 21 U.S.C
3/26/2010
H1N1 Pandemic Influeza - Peramivir AntiviralDetermination and Declaration Regarding Emergency Use of the Antiviral Product Peramivir
The Secretary declared an emergency justifying the authorization of emergency use of the antiviral product peramivir accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs (Commissioner) under 21 U.S.C.
10/23/2009
Bacillus anthracisRenewal of Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information
The Secretary of Health and Human Services is renewing the October 1, 2008 declaration by former Secretary Michael O. Leavitt of an emergency justifying the authorization of emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued by the Food and Drug Commissioner under 21 U.S.C.
10/1/2009
H1N1 Pandemic InfluenzaAuthorizations of Emergency Use of Certain Antiviral Drugs - Zanamivir and Oseltamivir Phosphate
FDA issued an EUA for certain products from the neuraminidase class of antivirals - Zanamivir and oseltamivir Phosephase.  These authorizations follow the determination by Acting HHS Secretary Charles Johnson that a public health emergency exists involving 2009 H1N1.
4/27/2009
H1N1 Pandemic InfluenzaAuthorziation of Emergency Use of Certain In Vitro Diagnostic Devices
FDA issued an EUA for cetain in vitro diagnostic devices.  The authorization follows the determination by Acting HHS Secretary Charles E. Johnson that a public health emergency exists involving 2009 H1N1.
4/27/2009
H1N1 Pandemic InfluenzaAuthorization of Emergency Use of Certain Personal Respiratory Protection Devices
FDA issued an EUA for certain personal respiratory protection devices.  The authorization follows the determination by Acting HHS Secretary Charles E. Johnson that a public health emergency exists involving 2009 H1N1
4/27/2009
Bacillus anthracisEmergency Use of Doxycycline Hyclate Tablets Accompanied by Emergnecy Use Information
Emergency use of doxycycline hyclate contianed in emergency kits for elidgable United States Postal Service Cities Readiness Initiative participants and their household members in advance of a potential attack involving Bacillus anthracis.
10/1/2008
Anthrax VaccineAuthorization of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax
The Secretary provides notice of the determination of the Department of Defense that there is a significant potential for a military emergency involving a heightened risk to United States military forces of attack with anthrax.
1/14/2005