Abstract：
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.
摘要：
美国食品和药物管理局（FDA）负责监督美国FDA使用的药物和疫苗的安全性和质量，这些药物和疫苗属于美国卫生与人类服务部（HHS）的管辖范围。FDA的监管是复杂而全面的,要求将各种角色和职责划分为六个主要中心。其中两个中心的活动，药物评价与研究中心(CDER)和生物制品评价与研究中心(CBER)是本综述的主要焦点.
