“…More than 140 diagnostic assays have been developed as of this date and have received the Food and Drug Administration (FDA) emergency use authorization (EUA). Given the differences in assasy format and/or design as well as the lack of rigorous verification studies, the performance and accuracy of these testing modalities remain unclear. …”
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“…The COVID-19 vaccine candidates currently in phase 3 or phase 2/3 clinical trials as well as those that recently received emergency use authorization (EUA) from the United States Food and Drug Administration (FDA) and/or other regulatory agencies worldwide require either cold (i.e., 2–8°C) or even freezing temperatures as low as −70°C for storage and distribution. …”
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“…MATERIAL/METHODS: A retrospective observational study was conducted in our institution on patients with underlying rheumatological disorders who received MAT as per the EUA protocol of the FDA. RESULTS: Two of the 4 patients were on immunosuppresive therapy at the time of receiving MAT. …”
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“…Post-vaccination response against SARS-CoV-2 was assessed using the FDA-EUA approved VITROS anti-SARS-CoV-2 IgG immunometric assay specific to the spike protein. …”
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“…Of all antibodies under EUA, the neutralisation potential of Etesevimab, Bamlanivimab, Casirivimab, Imdevima, Cilgavimab, Tixagevimab, Sotrovimab, and Regdanvimab might be dampened to varying degrees. …”
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“…CONCLUSION: This retrospective multicenter observational cohort study on 9,638 hospitalized patients with severe COVID-19 revealed that the necessity for invasive ventilation had the highest odds of mortality, beyond the variable effects observed by administration of the prevalent EUA-approved investigational drugs during the first two surges of the early 2020 pandemic in the United States.…”
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“…Os dados referentes ao Canadá são oriundos do COVID-19 Traker, e os dos Estados Unidos da América (EUA), do Departamento de Saúde e Serviços Humanos, enquanto dos demais países, China, Japão, Reino Unido (RU), Índia, Coreia do Sul e Brasil, advém de seus respectivos Centros de Vigilância governamentais. …”
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“…Remdesivir is an effective non-EUA U.S. Food and Drug Administration (FDA)-approved antiviral agent for the treatment of COVID-19 in hospitalized adult and pediatric patients, though a lack of data has prevented its use in patients with severe kidney disease including dialysis patients. …”
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“…Despite reported observational data about the experimental use of certain drugs, there is no conclusively proven curative therapy for COVID-19 as of now; however, remdesivir received emergency use authorization (EUA) by the Food and Drug Administration (FDA) recently for use in patients hospitalized with COVID-19. …”
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“…Here we address this question using over 27,500 test results for patients from across our healthcare network tested using the Abbott RealTime SARS-CoV-2 EUA. These results suggest that each 10-fold increase in LoD is expected to increase the false negative rate by 13%, missing an additional one in eight infected patients. …”
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“…In this review, we aim to present an objective overview of the latest nucleic acid-based diagnostic tests for the detection of SARS-CoV-2 that have been authorized by the Food and Drug Administration (FDA) under emergency use authorization (EUA) as of 31 October 2020. We systematically summarize and compare the principles, technologies, protocols and performance characteristics of amplification- and sequencing-based tests that have become alternatives to the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. …”
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“…In early December 2020, BNT162b2 received a temporary emergency use authorization (EUA) in the UK and, subsequently, a series of approvals or authorizations for emergency use in Bahrain, Canada, Mexico, Saudi Arabia and the USA. …”
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“…We would advocate for low threshold for performing an examination under anesthesia (EUA), with open repair of the stabilizing structures if persistently unstable after reduction.…”
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“…In the United States (U.S.), the need for rapid assay development and subsequent approval through the attainment of emergency use authorization (EUA) has superseded the traditional arduous diagnostic testing approval workflow mandated by the FDA. …”
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“…Using the OLS and threshold methods in the original time scales, we find that: (1) The EUA prices had an inverted U-shaped relationship with the number of new confirmed cases and deaths. (2) Government response policies had a better effect than fiscal policies when mitigating the negative impact of the pandemic. …”
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“…Out of the 550 San Mateo County outpatients with COVID-19 referred to Stanford University between July 2020 and April 2022, 9.5% elected to receive monoclonal antibody EUA treatment. COVID-19 treatment trial enrollment of County patients, 5% of those recruited, was commensurate with non-County populations enrollment. …”
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“…Current vaccines approved with emergency use authorization (EUA) were originally adaptive for adults only, and infants, children, and adolescents are not included. …”
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“…She underwent urgent (<48 h) EUA in theatres and her burns were tangentially shaved to active bleeding. …”
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“…The FDA has issued emergency use authorization (EUA) for hundreds of COVID-19 diagnostic tests of different classes. …”
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“…Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for remdesivir to treat COVID-19 patients. …”
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