利用监管科学促进公共卫生，以加强医疗产品的开发与监管：生物制品评估与研究中心的食品药品监督管理局研究
Advancing Public Health Using Regulatory Science to Enhance Development and Regulation of Medical Products: Food and Drug Administration Research at the Center for Biologics Evaluation and Research.
作者信息
Kusinitz Marc, Braunstein Emily, Wilson Carolyn A
机构信息
CBER, FDA, Silver Spring, MD, United States.
出版信息
Front Med (Lausanne). 2017 Jun 12;4:71. doi: 10.3389/fmed.2017.00071. eCollection 2017.
Abstract
Center for Biologics Evaluation and Research enhances and supports regulatory decision-making and policy development. This work contributes to our regulatory mission, advances medical product development, and supports Food and Drug Administration's regulatory response to public health crises. This review presents some examples of our diverse scientific work undertaken in recent years to support our regulatory and public health mission.
摘要
生物制品评估和研究中心加强并支持监管决策和政策制定。这项工作有助于我们的监管使命，推动医疗产品开发，并支持美国食品药品监督管理局对公共卫生危机的监管应对。本综述展示了我们近年来为支持监管和公共卫生使命而开展的各种科学工作的一些实例。
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3
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