emergency use authorization

noun

an authorization granted by the U.S. Food and Drug Administration during a public health emergency that allows for the use of a drug or other medical product prior to its full approval Especially during a shortage, much of the red tape needs to be cut away, much as formal review processes for new vaccines and drugs gave way to Emergency Use Authorizations during the pandemic.—Marc Siegel The U.S. Food and Drug Administration on Tuesday granted emergency use authorization for the Pfizer booster for this age group …—Aidin Vaziri called alsoEUA

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency …—fda.gov

noun

an authorization granted by the U.S. Food and Drug Administration during a public health emergency that allows for the use of a drug or other medical product prior to its full approval Especially during a shortage, much of the red tape needs to be cut away, much as formal review processes for new vaccines and drugs gave way to Emergency Use Authorizations during the pandemic.—Marc Siegel The U.S. Food and Drug Administration on Tuesday granted emergency use authorization for the Pfizer booster for this age group …—Aidin Vaziri called alsoEUA

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency …—fda.gov

The first known use of emergency use authorization was in 2003

emergency use authorizationnoun

an authorization granted by the U.S. Food and Drug Administration during a public health emergency that allows for the use of a drug or medical product prior to its full approval Based on these initial findings, the U.S. Food and Drug Administration has issued an Emergency Use Authorization for the emergency use of remdesivir for the treatment of hospitalized COVID-19 patients.—Richard T. Eastman et al., American Chemical Society Central Science called alsoEUA

During the 2009 influenza A (H1N1) pandemic, the Food and Drug Administration granted emergency use authorization of IV neuraminidase inhibitors for hospitalized patients with influenza, creating a need for rapid decision analyses to help guide use.—Bruce Y. Lee et al., The American Journal of Managed Care