Emergency Use Authorization (EUA)
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An Emergency Use Authorization (EUA) is a government authorization (granted to the Food And Drug Administration by the U.S. Government) that allows the use of an experimental treatment or medical device before regulatory approval.
- Context:
- It can range from being an Emergency Use Authorization for Vaccines to being an Emergency Use Authorizations for Medical Devices.
- Example(s):
- Counter-Example(s):
- See: Compassionate-Use Clinical Study, Drug, Medical Wearable Device, U.S. Drug Enforcement Administration, U.S. National Institute on Drug Abuse, Decentralized Clinical Trial, Observational Clinical Study, Placebo-Controlled Clinical Trial, Active-Treatment Controlled Clinical Trial.
References
2022
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Emergency_Use_Authorization Retrieved:2022-2-13.
- An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by , to allow the use of a drug prior to approval.[1] It does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes the FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.[1]
- ↑ 1.0 1.1 "Emergency Use Authorization of Medical Products and Related Authorities". US Food and Drug Administration. January 2017. Retrieved May 14, 2020.