一、主要機(jī)構(gòu)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(wèn)辦公室 Office of The Chief Counsel (職位:首席顧問(wèn)Chief Counsel)
●均等機(jī)會(huì)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(xué)協(xié)調(diào)和交流辦公室 Office of Science Coordination and Communication (職位:主任Director)
▲人體研究試驗(yàn)辦公室 Office For Human Research Trials
●資深準(zhǔn)專員辦公室 Office of The Senior Associate Commissioner (職位:資深準(zhǔn)專員Senior Associate Commissioner)
▲行政秘書(shū)處辦公室 Office of Executive Secretariat
▲公共事務(wù)辦公室 Office of Public Affairs
▲監(jiān)察專員辦公室 Office of The Ombudsman
▲罕見(jiàn)病產(chǎn)品開(kāi)發(fā)辦公室 Office of Orphan Products Development
▲內(nèi)部事務(wù)辦公室 Office of Internal Affairs
▲行政運(yùn)行辦公室 Office of Executive Operations
●國(guó)際和選民關(guān)系辦公室 Office of International & Constituent Relations (職位:副專員Deputy Commissioner)
▲國(guó)際項(xiàng)目辦公室 Office of International Programs
▲消費(fèi)者事務(wù)辦公室 Office of Consumer Affairs
▲婦女健康辦公室 Office of Women's Health
▲特殊健康問(wèn)題辦公室 Office of Special Health Issues
●政策、計(jì)劃和立法辦公室 Office of Policy, Planning, and Legislation (職位:資深準(zhǔn)專員Senior Associate Commissioner)
▲政策辦公室 Office of Policy
▲計(jì)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(zhǔn)專員Senior Associate Commissioner)
▲人類資源和管理服務(wù)辦公室 Office of Human Resources & Management Services
▲信息資源管理辦公室 Office of Information Resources Management
▲財(cái)務(wù)管理辦公室 Office of Financial Management
▲設(shè)備、辦公用品和中心服務(wù)辦公室 Office of Facilities, Acquisitions, & Central Services
生物制品評(píng)價(jià)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(shù)管理辦公室 Office of Information Technology Management
●執(zhí)法和生物制品質(zhì)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(xué)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(xùn)和幫助制造商辦公室 Office of Communication, Raining and Manufacturers Assistance
藥品評(píng)價(jià)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(xùn)和交流辦公室 Office of Raining and Communication
●執(zhí)法辦公室 Office of Compliance
●信息技術(shù)辦公室 Office of Information Technology
●醫(yī)學(xué)政策辦公室 Office of Medical Policy
●審查管理辦公室 Office of Review Management
▲藥品評(píng)價(jià)辦公室I Office of Drug Evaluation I
▲藥品評(píng)價(jià)辦公室II Office of Drug Evaluation II
▲藥品評(píng)價(jià)辦公室III Office of Drug Evaluation III
▲藥品評(píng)價(jià)辦公室IV Office of Drug Evaluation IV
▲藥品評(píng)價(jià)辦公室V Office of Drug Evaluation V
▲生物統(tǒng)計(jì)辦公室 Office of Biostatistics
▲上市后藥品風(fēng)險(xiǎn)評(píng)估辦公室 Office of Post-Marketing Drug Risk Assessment
●制藥科學(xué)辦公室 Office of Pharmaceutical Science
●臨床藥理學(xué)和生物制藥學(xué)辦公室 Office of Clinical Pharmacology and Biopharmceutics
●仿制藥品辦公室 Office of Generic Drugs
●新藥化學(xué)辦公室 Office of New Drug Chemistry
●試驗(yàn)和研究辦公室 Office of Testing and Research
食品安全和應(yīng)用營(yíng)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(xué)辦公室 Office of Science
◆應(yīng)用研究和安全性評(píng)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(yùn)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(chǎn)食品辦公室 Office of Seafood
▲現(xiàn)場(chǎng)項(xiàng)目辦公室 Office of Field Programs
▲科學(xué)分析和支持辦公室 Office of Scientific Analysis and Support
▲營(yíng)養(yǎng)產(chǎn)品、標(biāo)識(shí)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(píng)價(jià)辦公室 Office of Device Evaluation
●執(zhí)法辦公室 Office of Compliance
●科學(xué)和技術(shù)辦公室 Office of Science and Technology
●健康和產(chǎn)業(yè)項(xiàng)目辦公室 Office of Health and Industry Programs
●監(jiān)督和生物統(tǒng)計(jì)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(dòng)物藥評(píng)價(jià)辦公室 Office of New Animal Drug Evaluation
●研究辦公室 Office of Research
國(guó)家毒理學(xué)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(wù)辦公室 Office of Management Services
▲計(jì)劃、財(cái)務(wù)和信息技術(shù)辦公室 Office of Planning, Finance, and Information Technology
監(jiān)管事務(wù)辦公室 Office of Regulatory Affairs(ORA) (職位:準(zhǔn)專員Associate Commissioner)
●資源管理辦公室 Office of Resource Management
●強(qiáng)制執(zhí)法辦公室 Office of Enforcement
●地區(qū)性運(yùn)行辦公室 Office of Regional Operations
●犯罪調(diào)查辦公室 Office of Criminal Investigations
●地區(qū)性現(xiàn)場(chǎng)辦公室―中部地區(qū) Regional Field Office--Central Region
●地區(qū)性現(xiàn)場(chǎng)辦公室―東北地區(qū) Regional Field Office--Northeast Region
●地區(qū)性現(xiàn)場(chǎng)辦公室―太平洋地區(qū) Regional Field Office--Pacific Region
●地區(qū)性現(xiàn)場(chǎng)辦公室―東南地區(qū) Regional Field Office--Southeast Region
●地區(qū)性現(xiàn)場(chǎng)辦公室―西南地區(qū) Regional Field Office--Southwest Region
(據(jù)董 耿編譯:《浙江藥品監(jiān)督管理》2001年第7輯第82―85頁(yè))