摘要
美国FDA是医疗产品监管部门,在保护美国公众免于生物、化学、放射性/核威胁和新发流行性传染病威胁中起了至关重要的作用。美国FDA负责评审应对上述威胁的医疗应对产品包括药品、治疗用生物制剂、疫苗和器械的安全性和有效性,使用法律机制加快医疗应对产品的紧急使用,监控医疗应对产品的不良反应,与政府其他部门协同防范公共卫生威胁并作出反应。简介美国FDA的医疗应对产品评审政策、紧急使用以及FDA对公共卫生紧急事件的防范和应对措施。
The United States Food and Drug Administration(FDA)is the regulatory authority overseeing medical products and plays a critical role in protecting the public from chemical,biological,radiological,nuclear(CBRN)threats and emerging infectious diseases.It is responsible for reviewing the safety and efficacy of medical countermeasures(MCMs),including drugs,therapeutic biologics,vaccines,and devices;using legal mechanisms to facilitate emergency use;monitoring MCMs use for adverse events,and collaborating with government partners for preparedness and response.This article briefly introduces FDA regulations related to MCMs,emergency use and FDA preparedness and response to public health emergency.
作者
陈谨
徐然
赵东
杜涛
CHEN Jin;XU Ran;ZHAO Dong;DU Tao(Humphries Pharmaceutical Consulting,LLC.,Bethesda MD 20817,USA)
出处
《药学进展》
CAS
2020年第3期232-240,I0003,I0004,共11页
Progress in Pharmaceutical Sciences
关键词
公共卫生紧急事件
医疗应对产品
紧急使用授权
public health emergency
medical countermeasure
emergency use authorization
