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美國FDA的組織體系和主要職位設置

放大字體  縮小字體 發(fā)布日期:2014-08-15  來源:食品翻譯中心
核心提示:主要機構和職位示意圖、組織體系和主要職位。
一、主要機構和職位示意圖

 

 


二、組織體系和主要職位
    專員辦公室  Office of The Commissioner(OC) (職位:食品和藥品專員Commissioner of Food and Drugs;代理第一副專員Acting Principal Deputy Commissioner)
    ●首席顧問辦公室  Office of The Chief Counsel (職位:首席顧問Chief Counsel)
    ●均等機會辦公室  Office of Equal Opportunity (職位:主任Director)
    ●行政法官辦公室  Office of The Administrative Law Judge (職位:行政法官Administative Law Judge)
    ●科學協(xié)調和交流辦公室  Office of Science Coordination and Communication (職位:主任Director)
      ▲人體研究試驗辦公室  Office For Human Research Trials
    ●資深準專員辦公室  Office of The Senior Associate Commissioner (職位:資深準專員Senior Associate Commissioner)
      ▲行政秘書處辦公室  Office of Executive Secretariat
      ▲公共事務辦公室  Office of Public Affairs
      ▲監(jiān)察專員辦公室  Office of The Ombudsman
      ▲罕見病產品開發(fā)辦公室  Office of Orphan Products Development
      ▲內部事務辦公室  Office of Internal Affairs
      ▲行政運行辦公室  Office of Executive Operations
    ●國際和選民關系辦公室  Office of International & Constituent Relations (職位:副專員Deputy Commissioner)
      ▲國際項目辦公室  Office of International Programs
      ▲消費者事務辦公室  Office of Consumer Affairs
      ▲婦女健康辦公室  Office of Women's Health
      ▲特殊健康問題辦公室  Office of Special Health Issues
    ●政策、計劃和立法辦公室  Office of Policy, Planning, and Legislation (職位:資深準專員Senior Associate Commissioner)
      ▲政策辦公室  Office of Policy
      ▲計劃辦公室  Office of Planning
      ▲立法辦公室  Office of Legislation
    ●管理和系統(tǒng)辦公室  Office of Management & Systems (職位:資深準專員Senior Associate Commissioner)
      ▲人類資源和管理服務辦公室  Office of Human Resources & Management Services
      ▲信息資源管理辦公室  Office of Information Resources Management
      ▲財務管理辦公室 Office of Financial Management
      ▲設備、辦公用品和中心服務辦公室  Office of Facilities, Acquisitions, & Central Services
 
    生物制品評價和研究中心   Center For Biologics Evaluation and Research(CBER) (職位:主任Director)
    ●中心主任辦公室  Office of The Center Director
    ●管理辦公室  Office of Management
    ●信息技術管理辦公室  Office of Information Technology Management
    ●執(zhí)法和生物制品質量辦公室  Office of Compliance and Biologics Quality
    ●血液研究和審查辦公室  Office of Blood Research and Review
    ●治療學研究和審查辦公室  Office of Therapeutics Research and Review
    ●疫苗研究和審查辦公室  Office of Vaccines Research and Review
    ●交流、培訓和幫助制造商辦公室  Office of Communication, Raining and Manufacturers Assistance
 
    藥品評價和研究中心  Center For Drug Evaluation and Research(CDER) (職位:主任Director)
    ●中心主任辦公室  Office of The Center Director
    ●管理辦公室  Office of Management
    ●培訓和交流辦公室  Office of Raining and Communication
    ●執(zhí)法辦公室  Office of Compliance
    ●信息技術辦公室  Office of Information Technology
    ●醫(yī)學政策辦公室  Office of Medical Policy
    ●審查管理辦公室  Office of Review Management
      ▲藥品評價辦公室I  Office of Drug Evaluation I
      ▲藥品評價辦公室II  Office of Drug Evaluation II
      ▲藥品評價辦公室III  Office of Drug Evaluation III
      ▲藥品評價辦公室IV  Office of Drug Evaluation IV
      ▲藥品評價辦公室V  Office of Drug Evaluation V
      ▲生物統(tǒng)計辦公室  Office of Biostatistics
      ▲上市后藥品風險評估辦公室  Office of Post-Marketing Drug Risk Assessment
    ●制藥科學辦公室  Office of Pharmaceutical Science
    ●臨床藥理學和生物制藥學辦公室  Office of Clinical Pharmacology and Biopharmceutics
    ●仿制藥品辦公室  Office of Generic Drugs
    ●新藥化學辦公室  Office of New Drug Chemistry
    ●試驗和研究辦公室  Office of Testing and Research
 
    食品安全和應用營養(yǎng)中心  Center For Food Safety and Applied Nutrition(CFSAN) (職位:主任Director)
    ●中心主任辦公室  Office of The Center Director
      ▲科學辦公室  Office of Science
        ◆應用研究和安全性評估辦公室  Office of Applied Research and Safety Assessment
      ▲法規(guī)和政策辦公室  Office of Regulations and Policy
        ◆選民工作辦公室  Office of Constituent Operations
      ▲管理系統(tǒng)辦公室  Office of Management Systems
    ●運行辦公室  Office of Operations
      ▲化妝品和色素辦公室  Office of Cosmetics and Colors
      ▲上市前審批辦公室  Office of Premarket Approval
      ▲植物和牛奶食品及飲料辦公室  Office of Plant and Dairy Foods and Beverages
      ▲海產食品辦公室  Office of Seafood
      ▲現(xiàn)場項目辦公室  Office of Field Programs
      ▲科學分析和支持辦公室  Office of Scientific Analysis and Support
      ▲營養(yǎng)產品、標識和飲食添加劑辦公室  Office of Nutritional Products, Labeling and Dietary Supplements
 
    器械和輻射健康中心  Center For Devices and Radiological Health(CDR) (職位:主任Director)
    ●系統(tǒng)和管理辦公室  Office of Systems and Management
    ●器械評價辦公室  Office of Device Evaluation
    ●執(zhí)法辦公室  Office of Compliance
    ●科學和技術辦公室  Office of Science and Technology
    ●健康和產業(yè)項目辦公室  Office of Health and Industry Programs
    ●監(jiān)督和生物統(tǒng)計辦公室  Office of Surveillance and Biometrics
 
    獸藥中心  Center For Veterinary Medicine(CVM) (職位:主任Director)
    ●管理和交流辦公室  Office of Management and Communications
    ●監(jiān)督和執(zhí)法辦公室  Office of Surveillance and Compliance
    ●新動物藥評價辦公室  Office of New Animal Drug Evaluation
    ●研究辦公室  Office of Research
 
    國家毒理學研究中心  National Centers For Toxicological Research(NCR) (職位:主任Director)
    ●研究辦公室  Office of Research
    ●管理辦公室  Office of Management
      ▲管理服務辦公室  Office of Management Services
      ▲計劃、財務和信息技術辦公室  Office of Planning, Finance, and Information Technology
 
    監(jiān)管事務辦公室  Office of Regulatory Affairs(ORA) (職位:準專員Associate Commissioner)
    ●資源管理辦公室  Office of Resource Management
    ●強制執(zhí)法辦公室  Office of Enforcement
    ●地區(qū)性運行辦公室  Office of Regional Operations
    ●犯罪調查辦公室  Office of Criminal Investigations
    ●地區(qū)性現(xiàn)場辦公室―中部地區(qū)  Regional Field Office--Central Region
    ●地區(qū)性現(xiàn)場辦公室―東北地區(qū)  Regional Field Office--Northeast Region
    ●地區(qū)性現(xiàn)場辦公室―太平洋地區(qū)  Regional Field Office--Pacific Region
    ●地區(qū)性現(xiàn)場辦公室―東南地區(qū)  Regional Field Office--Southeast Region
    ●地區(qū)性現(xiàn)場辦公室―西南地區(qū)  Regional Field Office--Southwest Region
(據董  耿編譯:《浙江藥品監(jiān)督管理》2001年第7輯第82―85頁)
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