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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

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