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Volume 13, Number 7—July 2007
Policy Review

Emergency Use Authorization (EUA) to Enable Use of Needed Products in Civilian and Military Emergencies, United States

Stuart L. Nightingale*1Comments to Author , Joanna M. Prasher*, and Stewart Simonson*2

Author affiliations: *US Department of Health and Human Services, Washington, DC, USA;

Main Article

Table

Actions required before issuance of an EUA*

Step Required action Responsible authority
1 Determination of an emergency justifying issuance of an EUA Secretary of Homeland Security OR Secretary of Defense OR Secretary of Health and Human Services
2 Declaration of emergency Secretary of Health and Human Services
3 Consultation (to the extent feasible) between the FDA, NIH, and CDC FDA commissioner, NIH director, CDC director
4 Issuance of an EUA FDA commissioner (under delegated authority from Secretary of Health and Human Services)

*EUA, Emergency Use Authorization; FDA, US Food and Drug Administration; NIH, National Institutes of Health; CDC, Centers for Disease Control and Prevention.

Main Article

1Current affiliation: National Institutes of Health, Bethesda, Maryland, USA

2Current affiliation: Constella Group LLC, Washington, DC, USA

Page created: June 22, 2010
Page updated: June 22, 2010
Page reviewed: June 22, 2010
The conclusions, findings, and opinions expressed by authors contributing to this journal do not necessarily reflect the official position of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above.
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