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Regulatory Underpinnings of Global Health Security: FDAs Roles in Preventing Detecting and Responding to Global Health Threats

机译:全球健康安全的监管基础:FDA在预防发现和应对全球健康威胁中的作用

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摘要

In February 2014, health officials from around the world announced the Global Health Security Agenda, a critical effort to strengthen national and global systems to prevent, detect, and respond to infectious disease threats and to foster stronger collaboration across borders. With its increasing global roles and broad range of regulatory responsibilities in ensuring the availability, safety, and security of medical and food products, the US Food and Drug Administration (FDA) is engaged in a range of efforts in support of global health security. This article provides an overview of FDA's global health security roles, focusing on its responsibilities related to the development and use of medical countermeasures (MCMs) for preventing, detecting, and responding to global infectious disease and other public health emergency threats. The article also discusses several areas—antimicrobial resistance, food safety, and supply chain integrity—in which FDA's global health security roles continue to evolve and extend beyond MCMs and, in some cases, beyond traditional infectious disease threats.
机译:2014年2月,来自世界各地的卫生官员宣布了《全球卫生安全议程》,这是加强国家和全球系统以预防,发现和应对传染病威胁并促进跨境合作的重要举措。随着其在确保医疗和食品的可用性,安全性和安全性方面在全球范围内的作用日益增强和广泛的监管职责,美国食品和药物管理局(FDA)致力于支持全球健康安全的各种努力。本文概述了FDA在全球健康安全中的作用,重点是与开发和使用医学对策(MCM)预防,检测和应对全球传染病和其他公共卫生紧急威胁有关的责任。本文还讨论了抗菌素耐药性,食品安全和供应链完整性等多个领域,其中FDA的全球健康保障作用不断发展,并扩展到MCM以外,在某些情况下还超越了传统的传染病威胁。

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