Department of Pediatrics, SUNY Upstate Medical University, 750 East Adams Street, Syracuse, New York 13210, USA.
J Pediatric Infect Dis Soc. 2024 Jul 12;13(Supplement_2):S93-S102. doi: 10.1093/jpids/piae036.
The United States (U.S.) Food and Drug Administration (FDA) oversees the safety and quality of drugs and vaccines that are used in the U.S. Administration of the FDA falls under the jurisdiction of the U.S. Department of Health and Human Services (HHS). The regulatory oversight of the FDA is complex and comprehensive, requiring the various roles and responsibilities to be divided across six main centers. The activities of two of these centers, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are the primary focus of this review.
美国食品和药物管理局（FDA）负责监管在美国使用的药物和疫苗的安全性和质量。FDA 的管理隶属于美国卫生与公众服务部（HHS）。FDA 的监管工作复杂而全面，需要将各种角色和职责分配到六个主要中心。本次审查的重点是其中两个中心，即药品评估与研究中心（CDER）和生物制品评估与研究中心（CBER）的活动。
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