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CDER Organizational Chart
This is an organization chart. It includes one top level, 15 sublevels which report directly to the top level, various sub-sublevels which report directly to the 15 sublevels.
Office of the Center Director
Office of the Center Director
- Director
- Deputy Director
- Associate Director for Medical Informatics
- Associate Director for Planning and Business Informatics
- Associate Director for International Programs
- Associate Director for Safety Policy and Communication
- Associate Director for Policy
Office of Compliance
- Division of New Drugs and Labeling Compliance
- Division of Manufacturing and Product Quality
- Division of Scientific Investigations
- Division of Compliance Risk Management and Surveillance
Office of Counter-Terrorism and Emergency Coordination
- Office of Executive Programs
Office of Executive Programs
- Ombudsman
- Advisors and Consultant Staff
- Executive Operations Staff
- International Programs
- Quality Management Staff
Office of Information Technology
- Enterprise Architecture Staff
- Applied Technology Staff
- Division of Applications Development Services
Office of Management
- Division of Management and Budget
- Program and Resource Management
- Management and Analysis Branch
- Division of Management
- Program Management Services Branch
- Interface Management Branch
Office of Medical Policy
- Division of Drug Marketing, Advertising, and Communication
Office of New Drugs
- Guidance Policy Team
- Study Endpoints and Labeling Development Team
- Regulatory Affairs Team
- Pediatric and Maternal Health
- Pharmacology/Toxicology Staff
- Program Management Team
Office of Drug Evaluation 1:
- Botanical Review Team
- Division of Cardiovascular and Renal Products
- Division of Neurology Products
- Division of Psychiatry Products
Office of Drug Evaluation 2
- Division of Anesthesia, Analgesia and Rheumatology Products
- Division of Metabolism and Endocrinology Products
- Division of Pulmonary and Allergy Products
Office of Drug Evaluation 3
- Division of Gastroenterology Products
- Divison of Dermatology and Dental Products
- Division of Reproductive and Urologic Products
Office of Antimicrobial Products
- Drug Shortages Program
- Antimicrobial Resistance Initiative
- Division of Anti-Infective and Ophthalmologic Products
- Division of Antiviral Products
- Division of Special Pathogens and Transplant Products
Office of Oncology Drug Products
- Division of Drug Oncology Products
- Division of Medical Imaging and Hematology Products
- Division of Biological Oncology Products
Office of Nonprescription Products
- Division of Nonprescription Regulation Development
- Division of Nonprescription Clinical Evaluation
Office of Pharmaceutical Science
- Operations Staff
- Program Activites Review Staff
- Standards and Technology Team
- Science and Research Staff
- Informatics and Computational Safety Analysis Staff
- New Drug Microbiology Team
- Process Analytical Technologies
Office of Testing and Research
- Laboratory of Clinical Pharmacology
- Division of Applied Pharmacology Research
- Division of Pharmaceutical Analysis
- Division of Product Quality
Office of Generic Drugs
- Division of Labeling and Program Support
- Division of Chemistry 1
- Division of Chemistry 2
- Division of Chemistry 3
- Division of Bioequivalence
Office of Biotechnology Products
- Division of Therapeutic Proteins
- Division of Monoclonal Antibodies
.Office of New Drug Quality Assessment
- Division of Pre-Marketing Assessment 1
- Division of Pre-Marketing Assessment 2
- Division of Pre-Marketing Assessment 3
- Division of Post-Marketing Evaluation
Office of Planning and Informatics
- Office of Planning and Analysis
- Analyst Staff
- Planning and Evaluation Staff
- Office of Business Process Support
- Division of Regulatory Review Support
- Division of Project Development Staff
- Division of Records Management
- Division of Business Analysis and Reporting Staff
Office of Regulatory Policy
- Division of Regulatory Policy 1
- Division of Regulatory Policy 2
- Division of Information Disclosure Policy
Office of Surveillance and Epidemiology
- Business Process Improvement Staff
- Review Management Staff
- Regualtory Policy Staff
- Division of Risk Management
- Division of Epidemiology
- Division of Medical Errors Prevention
- Division of Pharmacovigilance 1
- Division of Pharmacovigilance 2
Office of Training and Communications
- Division of Public Affairs
- Division of Training and Development
- Division of Information Services
- Division of Drug Information
Office of Translational Sciences
- Program Management Team
- Office of Biostatistics
- Division of Biometrics 1
- Division of Biometrics 2
- Division of Biometrics 3
- Division of Biometrics 4
- Division of Biometrics 5
- Division of Biometrics 6
- Office of Clinical Pharmacology
- Pharmacometrics Staff
- Division of Clinical Pharmacology 1
- Division of Clinical Pharmacology 2
- Division of Clinical Pharmacology 3
- Division of Clinical Pharmacology 4
- Division of Clinical Pharmacology 5
Safety Policy and Communication Staff
- MedWatch
- Drug Safety Oversight Board
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Date created: August 15, 2008; Last updated: January 12, 2009 |
