“…Relationships relative to FDA-approved cutoffs under the CCP EUA were identified by linear regression and receiver operator characteristic curves. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…Food and Drug Administration (FDA) recently issued an Emergency Use Authorization (EUA) for two highly effective Sars-CoV-2 (COVID-19) vaccines from Pfizer-BioNTech and Moderna. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…Dozens of RT-qPCR kits are available in the market for SARS-CoV-2 diagnosis, some of them with Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) or at least by a responsible agency of their country of origin, but many of them lack proper evaluation studies because of COVID-19 pandemic emergency. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…Despite available vaccines and EUA, pharmacological therapy for the prevention and treatment of COVID-19 is still highly required. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…PURPOSE: In the United States, Pfizer-BioNTech, Moderna, and Janssen’s coronavirus disease 2019 (COVID-19) vaccines have been granted Emergency Use Authorization (EUA) with the Pfizer-BioNTech vaccine presently approved by the US Food and Drug Administration. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…BACKGROUND: Dozens of commercial RT-qPCR kits for SARS-CoV-2 detection are available with or without Emergency Use Authorization (EUA) by FDA or other regulatory agencies. OBJECTIVE: We evaluated the clinical performance of two SARS-CoV-2 RT-PCR kits designed and produced in South America, "COVID-19 RT-PCR Real TM FAST (CY5)" (ATGen, Uruguay) and "ECUGEN SARS-CoV-2 RT-qPCR" (UDLA-STARNEWCORP, Ecuador), for RT-qPCR SARS-CoV2 detection using "TaqMan 2019-nCoV Assay Kit v1" (Thermofisher, USA) as a gold standard technique. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…We performed our study with two different approaches, first with validation method consisting of 188 samples (2 batches) on cobas 6800 instrument (Roche Molecular Systems, Branchburg, NJ) soon after we received US FDA EUA on 1 June 2021, all these samples were tested earlier with laboratory designed tests on 25th and 26th May 2021. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…Casirivimab/imdevimab received emergency use authorization (EUA) for the prophylaxis and treatment of COVID 19 disease. …”
Enlace del recurso
Enlace del recurso

“…BACKGROUND: Numerous nucleic acid amplification assays have recently received emergency use authorization (EUA) for the diagnosis of SARS-CoV-2 infection, and there is a need to assess their test performance relative to one another. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…Food and Drug Administration (FDA) recently granted several commercial SARS-CoV-2 tests Emergency Use Authorization (EUA), but manufacturer-independent evaluation data are scarce. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…Several point-of-care (POC) molecular tests have received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…Multiple molecular diagnostic methods received FDA emergency use authorization (EUA) and were promptly validated for use nationwide. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…Food and Drug Administration subsequently instituted an Emergency Use Authorization (EUA) procedure requiring that manufacturers submit validation data, but allowing newly developed serological tests to be marketed without the usual approval process during this crisis. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…OBJECTIVE: We carried out an evaluation of the clinical performance of "AccuPower SARS-CoV-2 Real Time RT-PCR kit" (Bioneer, South Korea) for SARS-CoV-2 diagnosis using 2019-nCoV CDC EUA kit (IDT, USA) as a gold standard. RESULTS: 48 clinical specimens were included on the study, 38 tested SARS-CoV-2 positive and 10 SARS-CoV-2 negative for 2019-nCoV CDC EUA kit. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…RESULTS: Quantitative SARS-CoV-2 IgG results have been reported from a limited number of studies; most studies used in-house laboratory-developed tests in limited settings, and only two semiquantitative tests have received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA). As of November 6, 2020, there is only one SARS-CoV-2 neutralization assay with FDA EUA. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…BACKGROUND: Recombinant monoclonal antibody therapies have been utilized under emergency use authorization (EUA) for the prevention of clinical decompensation in high-risk COVID-19 positive patients for up to 10 days from symptom onset. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…Due to limited data on its outcomes and the logistic challenges in administering the drug, MAT has not been widely used in the United States (US) despite of emergency use authorization (EUA) approval by the Food and Drug Administration (FDA). …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…Within the EMR, an order panel was implemented to assure that the key requirements of the EUA were met and the provider was guided to the appropriate mAB, nursing, and PRN rescue medication orders. …”
Enlace del recurso
Enlace del recurso

“…BACKGROUND AND AIMS: Molnupiravir is a newer oral antiviral drug that has recently received emergency use authorization (EUA) in USA, UK and India. We aim to conduct an update on our previous systematic review to provide practical clinical guideline for using molnupiravir in patients with COVID-19. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso

“…As per the EUA, all SARS-CoV-2 positive organ transplant recipients can receive mAb treatment. …”
Enlace del recurso
Enlace del recurso
Enlace del recurso