Emergency Use Authorization
From Self-sufficiency
An Emergency Use Authorization (EUA), in the United States is a legal means for the Food and Drug Administration (FDA) to approve new drugs or new indications for previously approved drugs during a declared emergency.[1]
Response to swine influenza epidemic
In response to requests from the U.S. Centers for Disease Control and Prevention, on April 27, 2009 the FDA issued Emergency Use Authorizations to make available diagnostic and therapeutic tools to identify and respond to the 2009 swine flu outbreak under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral drugs, and for the rRT-PCR Swine Flu Panel diagnostic test.[2]
References
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- ↑ U.S. Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Counterterrorism Policy and Planning Guidance: Emergency Use Authorization of Medical Products. July 2007.
- ↑ FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans. FDA News, April 27, 2009.
