ABSTRACT

Emergency Use Authorization of Medical Products Guidance - Emergency Use Authorization of Medical Products   [open pdf - 290KB]

"This guidance explains FDA's [Food and Drug Administration] policies for authorizing the emergency use of medical products under section 564 of the Federal Food, Drug, and Cosmetic Act.... Section 564 permits the FDA Commissioner to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security. The Emergency Use Authorization (EUA) authority recently granted by Congress 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, 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. The document is intended to inform industry, government agencies, and FDA staff of the Agency's general recommendations and procedures for issuance of EUAs.3 FDA expects that requests for consideration for an EUA would be submitted by government agencies (e.g., the Department of Health and Human Services or the Department of Defense (DoD)) or private entities. FDA may seek additional data and information on a case-by-case basis to ensure that the statutory criteria for issuance of an EUA are met."

Publisher:
Date:
2007-07
Copyright:
Public Domain
Retrieved From:
U.S Food and Drug Administration: http://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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