The Red Flag of Emergency Use Authorization (Eua)

Abstract

The Emergency Use Authorization (EUA) policy, a representative biodefense policy, was legislated in the United States in 2001 based on lessons learned from Amerithrax, whereas Korea's EUA policy was based on lessons learned from the Middle East Respiratory Syndrome outbreak in 2015. Due to these divergent origins, the U.S. EUA's homeland security objectives were specialized to deal with highly pathogenic biological agents that could be exploited for bioterrorism, whereas the Korean EUA pursues disease containment purposes to strengthen mass-testing practices. During the early phase of the COVID-19 pandemic, the U.S. EUA revealed limitations in its integration with public health surveillance, laboratory partnerships, and insurance systems, which hampered the rapid expansion of testing capacities. Thereafter, once the limitations of the EUA were circumvented, the testing capacity of the United States began to catch up with that of South Korea, and later skyrocketed after solving these issues.

Engineered two-dimensional nanomaterials based diagnostics integrated with internet of medical things (IoMT) for COVID-19

“…Due to the rapid spread of COVID-19, the FDA has begun issuing Emergency Use Authorization (EUA) for multiple COVID-19 diagnostic tests (Table 3). 369 Notably, experiments with the FDA-EUA status are not granted full FDA approval, 370 instead their authorizations are only valid for the duration of the pandemic. EUA assays for COVID-19 are administered by the clinical laboratory.…”

Note From the Editor

“…Next, we have two articles dealing in depth with aspects of the pandemic concerning the transnational effect(s) of COVID-19 on stock indexes (Tavor and Teitler-Regev 2023) and an illuminating study comparing institutional conflict resulting in different COVID-19 testing outcomes in the United States and South Korea (Kim 2023). This last paper is highly recommended reading for its breadth of information as much as the solidity (and rather sobering conclusions) of its comparative analysis.…”