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Emergency Use Authorization

Date of Publication

2/27/2008

Definition

An authorization from the FDA under section 564 of Reference (d) with respect to an unapproved product that allows, based on a declaration of emergency by the Secretary of Health and Human Services, the product to be introduced into interstate commerce for use or for the intended use, subject to terms and conditions established by the FDA.  An EUA for an unapproved product exempts the product, within the terms of the EUA, from requirements applicable to investigational new drug.

Source of Definition

DoD Instruction 6200.02: Application of FDA Rules to Department of Defense Force Health Protection Programs

Related Glossary Terms

Emergency Use Authorization

Last Updated: August 01, 2022

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