Emergency Use Authorization

OVERVIEW

The Emergency Use Authorization (EUA) authority allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological, and nuclear agents that may be used to attack the American people or the U.S. armed forces.  Under section 564 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3), which was amended by the Project Bioshield Act of 2004 (public Law 108-276), the FDA Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved and available alternatives.  For more information about EUA go to www.fda.newsevents/publichealthfocus/ucm153297.

GUIDANCE

FDA developed guidance explaining FDA's policies for authorizing the emergency use of medical products under section 564 of the Federal Food, Drug, and Cosmetic Act.  The guidance is intended to inform industry, government agencies, and FDA staff of the Agency's general recommendation and procedures for issuance of EUAs.  The guidance can be found at www.fda.gov/regulatoryinformation/guidances/ucm125127.