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美国FDA的组织体系和主要职位设置

放大字体  缩小字体 发布日期:2014-08-15  来源:食品翻译中心
核心提示:主要机构和职位示意图、组织体系和主要职位。
一、主要机构和职位示意图

 

 


二、组织体系和主要职位
    专员办公室  Office of The Commissioner(OC) (职位:食品和药品专员Commissioner of Food and Drugs;代理第一副专员Acting Principal Deputy Commissioner)
    ●首席顾问办公室  Office of The Chief Counsel (职位:首席顾问Chief Counsel)
    ●均等机会办公室  Office of Equal Opportunity (职位:主任Director)
    ●行政法官办公室  Office of The Administrative Law Judge (职位:行政法官Administative Law Judge)
    ●科学协调和交流办公室  Office of Science Coordination and Communication (职位:主任Director)
      ▲人体研究试验办公室  Office For Human Research Trials
    ●资深准专员办公室  Office of The Senior Associate Commissioner (职位:资深准专员Senior Associate Commissioner)
      ▲行政秘书处办公室  Office of Executive Secretariat
      ▲公共事务办公室  Office of Public Affairs
      ▲监察专员办公室  Office of The Ombudsman
      ▲罕见病产品开发办公室  Office of Orphan Products Development
      ▲内部事务办公室  Office of Internal Affairs
      ▲行政运行办公室  Office of Executive Operations
    ●国际和选民关系办公室  Office of International & Constituent Relations (职位:副专员Deputy Commissioner)
      ▲国际项目办公室  Office of International Programs
      ▲消费者事务办公室  Office of Consumer Affairs
      ▲妇女健康办公室  Office of Women's Health
      ▲特殊健康问题办公室  Office of Special Health Issues
    ●政策、计划和立法办公室  Office of Policy, Planning, and Legislation (职位:资深准专员Senior Associate Commissioner)
      ▲政策办公室  Office of Policy
      ▲计划办公室  Office of Planning
      ▲立法办公室  Office of Legislation
    ●管理和系统办公室  Office of Management & Systems (职位:资深准专员Senior Associate Commissioner)
      ▲人类资源和管理服务办公室  Office of Human Resources & Management Services
      ▲信息资源管理办公室  Office of Information Resources Management
      ▲财务管理办公室 Office of Financial Management
      ▲设备、办公用品和中心服务办公室  Office of Facilities, Acquisitions, & Central Services
 
    生物制品评价和研究中心   Center For Biologics Evaluation and Research(CBER) (职位:主任Director)
    ●中心主任办公室  Office of The Center Director
    ●管理办公室  Office of Management
    ●信息技术管理办公室  Office of Information Technology Management
    ●执法和生物制品质量办公室  Office of Compliance and Biologics Quality
    ●血液研究和审查办公室  Office of Blood Research and Review
    ●治疗学研究和审查办公室  Office of Therapeutics Research and Review
    ●疫苗研究和审查办公室  Office of Vaccines Research and Review
    ●交流、培训和帮助制造商办公室  Office of Communication, Raining and Manufacturers Assistance
 
    药品评价和研究中心  Center For Drug Evaluation and Research(CDER) (职位:主任Director)
    ●中心主任办公室  Office of The Center Director
    ●管理办公室  Office of Management
    ●培训和交流办公室  Office of Raining and Communication
    ●执法办公室  Office of Compliance
    ●信息技术办公室  Office of Information Technology
    ●医学政策办公室  Office of Medical Policy
    ●审查管理办公室  Office of Review Management
      ▲药品评价办公室I  Office of Drug Evaluation I
      ▲药品评价办公室II  Office of Drug Evaluation II
      ▲药品评价办公室III  Office of Drug Evaluation III
      ▲药品评价办公室IV  Office of Drug Evaluation IV
      ▲药品评价办公室V  Office of Drug Evaluation V
      ▲生物统计办公室  Office of Biostatistics
      ▲上市后药品风险评估办公室  Office of Post-Marketing Drug Risk Assessment
    ●制药科学办公室  Office of Pharmaceutical Science
    ●临床药理学和生物制药学办公室  Office of Clinical Pharmacology and Biopharmceutics
    ●仿制药品办公室  Office of Generic Drugs
    ●新药化学办公室  Office of New Drug Chemistry
    ●试验和研究办公室  Office of Testing and Research
 
    食品安全和应用营养中心  Center For Food Safety and Applied Nutrition(CFSAN) (职位:主任Director)
    ●中心主任办公室  Office of The Center Director
      ▲科学办公室  Office of Science
        ◆应用研究和安全性评估办公室  Office of Applied Research and Safety Assessment
      ▲法规和政策办公室  Office of Regulations and Policy
        ◆选民工作办公室  Office of Constituent Operations
      ▲管理系统办公室  Office of Management Systems
    ●运行办公室  Office of Operations
      ▲化妆品和色素办公室  Office of Cosmetics and Colors
      ▲上市前审批办公室  Office of Premarket Approval
      ▲植物和牛奶食品及饮料办公室  Office of Plant and Dairy Foods and Beverages
      ▲海产食品办公室  Office of Seafood
      ▲现场项目办公室  Office of Field Programs
      ▲科学分析和支持办公室  Office of Scientific Analysis and Support
      ▲营养产品、标识和饮食添加剂办公室  Office of Nutritional Products, Labeling and Dietary Supplements
 
    器械和辐射健康中心  Center For Devices and Radiological Health(CDR) (职位:主任Director)
    ●系统和管理办公室  Office of Systems and Management
    ●器械评价办公室  Office of Device Evaluation
    ●执法办公室  Office of Compliance
    ●科学和技术办公室  Office of Science and Technology
    ●健康和产业项目办公室  Office of Health and Industry Programs
    ●监督和生物统计办公室  Office of Surveillance and Biometrics
 
    兽药中心  Center For Veterinary Medicine(CVM) (职位:主任Director)
    ●管理和交流办公室  Office of Management and Communications
    ●监督和执法办公室  Office of Surveillance and Compliance
    ●新动物药评价办公室  Office of New Animal Drug Evaluation
    ●研究办公室  Office of Research
 
    国家毒理学研究中心  National Centers For Toxicological Research(NCR) (职位:主任Director)
    ●研究办公室  Office of Research
    ●管理办公室  Office of Management
      ▲管理服务办公室  Office of Management Services
      ▲计划、财务和信息技术办公室  Office of Planning, Finance, and Information Technology
 
    监管事务办公室  Office of Regulatory Affairs(ORA) (职位:准专员Associate Commissioner)
    ●资源管理办公室  Office of Resource Management
    ●强制执法办公室  Office of Enforcement
    ●地区性运行办公室  Office of Regional Operations
    ●犯罪调查办公室  Office of Criminal Investigations
    ●地区性现场办公室―中部地区  Regional Field Office--Central Region
    ●地区性现场办公室―东北地区  Regional Field Office--Northeast Region
    ●地区性现场办公室―太平洋地区  Regional Field Office--Pacific Region
    ●地区性现场办公室―东南地区  Regional Field Office--Southeast Region
    ●地区性现场办公室―西南地区  Regional Field Office--Southwest Region
(据董  耿编译:《浙江药品监督管理》2001年第7辑第82―85页)
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