就在上周四(2021年7月22日),FDA向Becton Dickinson颁发了紧急使用授权书(EUA),用于收集、运输和储存血液样本进行凝血检测,以帮助识别和治疗已知或疑似COVID-19患者的凝血病。 这也是第一款和目前唯一一款获得FDA 紧急使用授权书的血液样本采集管(简称:采血管)。目前来看,美国市场对采血管,尤其是柠檬酸钠管(蓝帽)处...
Fact Sheet - Patients (SPANISH) FDA Letter of Authorization AUTHORIZED USE Sotrovimab is authorized for use under an Emergency Use Authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing...
a Patients ≥12 years old who weigh ≥40 kg with ≥1 of the criteria listed are considered at high risk for progressing to severe COVID-19 and/or hospitalization. FDA fact sheet for health care providers emergency use authorization (EUA) of bamlanivimab. Available at: https://www.fda.gov...