摘要
医疗产品的使用在突发公共卫生事件的处置中具有重要作用。作为医疗产品的监管机构,美国FDA在评估其安全性、有效性、可及性方面,发挥着无可替代的作用。该文就FDA在COVID-19疫情中关于医疗产品的应对措施及其特点进行分析,为我国药品监督管理部门制定决策提供参考。
The use of medical products plays an important role in dealing with a public health emergency.As the regulatory agency of medical products,the FDA plays an irreplaceable role in evaluating its safety,effectiveness and accessibility.This article analyzes the countermeasures related to medical products taken by the FDA in COVID-19 pandemic so as to provide reference for the drug regulatory authorities in China.
作者
葛华
蒋丽勇
刘术
刁天喜
GE Hua;JIANG Li⁃yong;LIU Shu;DIAO Tian⁃xi(Institute of Health Service and Transfusion Medicine,Academy of Military Medical Sciences,Academy of Military Sciences,Beijing 100850,China)
出处
《军事医学》
CAS
北大核心
2020年第7期481-484,共4页
Military Medical Sciences
