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1
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34447292867
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Emergency Use Authorization (EUA) to enable use of needed products in civilian and military emergencies United States
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Accessed September 10, 2009
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Nightingale SL, Prasher JM, Simonson S. Emergency Use Authorization (EUA) to enable use of needed products in civilian and military emergencies, United States. Emerg Infect Dis 2007;13(7):1046-1051. http:==www.cdc.gov=EID= content=13=7=1046.htm. Accessed September 10, 2009.
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(2007)
Emerg Infect Dis
, vol.13
, Issue.7
, pp. 1046-1051
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Nightingale, S.L.1
Prasher, J.M.2
Simonson, S.3
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2
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70350144146
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Authorization for Medical Products for Use in Emergencies, 21 U.S.C. 360bbb-3
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Authorization for Medical Products for Use in Emergencies, 21 U.S.C. 360bbb-3.
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3
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70350181597
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If the Secretary determines, after consultation with such public health officials as may be necessary, that-(1) a disease or disorder presents a public health emergency; or (2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists. . . .'' 42 U.S.C. 247d
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''If the Secretary determines, after consultation with such public health officials as may be necessary, that-(1) a disease or disorder presents a public health emergency; or (2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists. . . .'' 42 U.S.C. 247d.
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4
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70350159910
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For further information about submitting EUA applications to FDA, please see HHS, FDA, Office of the Commissioner, Office of Counterterrorism Policy and Planning. July Accessed September 10, 2009
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For further information about submitting EUA applications to FDA, please see HHS, FDA, Office of the Commissioner, Office of Counterterrorism Policy and Planning. Emergency Use Authorization of Medical Products: Guidance-Emergency Use Authorization of Medical Products. July 2007. http:== www.fda.gov= RegulatoryInformation=Guidances=ucm125127. Accessed September 10, 2009.
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(2007)
Emergency Use Authorization of Medical Products: Guidance-Emergency Use Authorization of Medical Products
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5
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70350135826
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Targeted Liability Protections for Pandemic and Epidemic Products and Security Countermeasures, 42 U.S.C. 247d-6d
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Targeted Liability Protections for Pandemic and Epidemic Products and Security Countermeasures, 42 U.S.C. 247d-6d.
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6
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70350149423
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See also, U.S. Department of Health and Human Services. Accessed September 10, 2009
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See also, U.S. Department of Health and Human Services. Public Readiness and Emergency Preparedness Act Questions and Answers. http:==www.hhs.gov= disasters= emergency= manmadedisasters=bioterorism=medication-vaccine-qa.html. Accessed September 10, 2009.
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Public Readiness and Emergency Preparedness Act Questions and Answers
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7
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70350154368
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A list of current PREP Act declarations issued by the HHS Secretary is available at Accessed September 10, 2009
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A list of current PREP Act declarations issued by the HHS Secretary is available at: http:==www.hhs.gov=disasters= discussion=planners=prepact=. Accessed September 10, 2009.
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8
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70350141990
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The Secretary renewed the declaration on July 24, 2009. The Acting Secretary's declaration of a public health emergency and the Secretary's renewal of that declaration are available at
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The Secretary renewed the declaration on July 24, 2009. The Acting Secretary's declaration of a public health emergency and the Secretary's renewal of that declaration are available at: http:==www.hhs.gov=secretary=phe-swh1n1. html. Accessed September 23, 2009.
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9
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70350138925
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Notice of the 3 declarations justifying emergency use and the first 5 EUAs may be found at 74 Fed Reg. 38628, 38636, 38644, 38648 (August 4, 2009)
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Notice of the 3 declarations justifying emergency use and the first 5 EUAs may be found at 74 Fed. Reg. 38628, 38636, 38644, 38648 (August 4, 2009).
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10
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70350149424
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For more information about the EUAs, see Accessed September 10, 2009
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For more information about the EUAs, see http:==www.cdc. gov=h1n1flu=eua=. Accessed September 10, 2009.
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11
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70350181598
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The FDA also approved 4 vaccines against H1N1 on September 15, 2009. More information can be found at. Accessed September 24, 2009
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The FDA also approved 4 vaccines against H1N1 on September 15, 2009. More information can be found at http:==www. fda.gov=NewsEvents=Newsroom= PressAnnouncements=ucm 182399.htm. Accessed September 24, 2009.
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