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Emergency use authorization

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As the name suggests, The Emergency Use Authorization (EUA) authority allows the United States Food and Drug Administration (FDA) to help strengthen the nation’s public health protections against any chemical, biological, radiological, and nuclear (cbrn) threat by facilitating the availability and use of Medical CounterMeasures (MCM)s needed during public health emergencies.

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  • Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.
  • Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017.

FDA approval information for Emergency use authorization

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