Antiviral Emergency Use Authorization (EUA)

Licensed vaccines and drugs, or approved therapeutics and medical devices treat, prevent, or mitigate disease. If an emerging public health threat is identified for which no licensed or approved product exists, the Project BioShield Act of 2004 authorizes the FDA Commissioner to issue an EUA so appropriate countermeasures (e.g., distribution of unlicensed antiviral medications) can be taken quickly to protect the safety of the U.S. population. Specifically, these countermeasures can facilitate the diagnosis, treatment, or prevention of serious or life-threatening diseases, or for conditions caused by chemical, biologic, or radiologic agents for which no adequate, approved, or available alternatives exist. CDC in conjunction with NIH provides expert consultation to the FDA Commissioner regarding the appropriateness of EUA requests and supports the distribution of products stored in the Strategic National Stockpile (SNS) formulary [234]. EUAs in effect during the 2009 H1N1 pandemic have expired because there is no longer a declared emergency.

Review the references cited in this guidance.