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| H1N1 Pandemic Influenza | Authorizations 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. | April 27, 2009 | | H1N1 Pandemic Influenza | Authorziation 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. | April 27, 2009 | | H1N1 Pandemic Influenza | Authorization 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 | April 27, 2009 | | Bacillus anthracis | Emergency 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. | October 1, 2008 | | Bacillus anthracis | Renewal 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). | October 1, 2010 |
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