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
●执法和生物制品雷竞技百科 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)