Emergency Use Authorization
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 powerful antiviral drugs, and for the quantitative PCR Swine Flu test.[2]
Potential emergencies
On April 22, 2013, the FDA issued an Emergency Use Authorization (EUA) for the CDC Human Influenza Virus quantitative PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay. This test is for the presumptive detection of novel influenza A (H7N9) virus.[3]
On June 5, 2013, the FDA issued an Emergency Use Authorization (EUA) for the CDC Novel Coronavirus 2012 quantitative PCR Assay. This test is for the presumptive detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV), formerly known as Novel Coronavirus 2012 or NCV-2012.[4]
References
- ↑ 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.
- ↑ Emergency Situations (Medical Devices) > Emergency Use Authorizations FDA, June 10, 2013.
- ↑ Emergency Situations (Medical Devices) > Emergency Use Authorizations FDA, June 10, 2013.