Examples of EUA in a sentence
During the 2nd half of the year, the monthly volume regularly went beyond 30 Mio EUA (= EU Allowances, with 1 EUA = 1 ton CO2).
Last year, a CDC scientist and expert on arboroviruses, who later became a whistleblower, alleged that CDC endangered public health when it failed to disclose that the CDC test used to detect the Zika virus, known as a Trioplex (an FDA EUA), was less sensitive than another CDC laboratory-developed test (not authorized under FDA EUA), known as a Singleplex.51 Following an Office of Special Counsel investigation, CDC agreed to reinstate the scientist.
Paxlovid has not been approved, but has been authorized for emergency use by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA), for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death.
Categories of Products: The range of potential EUA products includes drugs, biological products (e.g., vaccine, blood products, and biological therapeutics), and devices (e.g., in vitro diagnostics).
This section discusses FDA's role in pre-emergency activities for candidate EUA products, as well as the procedures the Agency will follow in processing a request for consideration for an EUA once the Secretary has issued a declaration of emergency.