Emergency use authorization
An Emergency Use Authorization is an authority granted to the Food and Drug Administration. It authorizes FDA to facilitate availability of an unapproved product. EUAs may be applied to drugs, devices or biological product. They can only be implemented during a public health emergency.
About Emergency use authorization in brief
An Emergency Use Authorization is an authority granted to the Food and Drug Administration. It authorizes FDA to facilitate availability of an unapproved product. EUAs may be applied to drugs, devices or biological product. They can only be implemented during a public health emergency as defined by a declaration of the Secretary of Health and Human Services. The scope and applicability of EUAs is also affected by presidential executive orders, which may affect the definition of the situations considered to be public health emergencies, and under which the authority of the FDA to issue EUAs can be exercised.
The FDA issued Emergency Use Authorizations to make available diagnostic and therapeutic tools to identify and respond to the 2009 swine flu pandemic under certain circumstances. The agency issued these EUAs for the use of certain powerful antiviral drugs, and for the quantitative PCR Swine Flu test. On April 22, 2013, the FDA issued an EUA for the CDC Human Influenza Panel-Influenza AH7 Assay. This test is the presumptive detection of novel novel virus A.
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This page is based on the article Emergency use authorization published in Wikipedia (as of Nov. 10, 2020) and was automatically summarized using artificial intelligence.
