CDER Offices and Divisions

Offices

• Office of the Center Director
  • Advisory Committee Staff 
  • Controlled Substance Staff
• Office of Compliance
  • Division of Compliance Risk Management and Surveillance
  • Division of Manufacturing and Product Quality
  • Division of New Drugs and Labeling Compliance
  • Division of Scientific Investigations
• Office of Medical Policy
  • Division of Drug Marketing, Advertising and Communications
• Office of New Drugs 
  •  Realignment in the Office of New Drugs
• Office of Nonprescription Products
• Office of Oncology Drug Products
  • Radioactive Drug Research Committee (RDRC) Program
• Office of Pharmaceutical Science
  • Office of Biotechnology Products
  • Office of Generic Drugs
  • Office of New Drug Quality Assessment
  • Office of Testing and Research
    • Division of Applied Pharmacology Research
    • Division of Pharmaceutical Analysis
    • Division of Product Quality Research
  • Informatics and Computational Safety Analysis Staff (ICSAS)
• Office of Surveillance and Epidemiology (formerly Office of Drug Safety)
• Office of Translational Sciences
  • Office of Biostatistics
  • Office of Clinical Pharmacology
    • Pharmacometrics Staff

Divisions

• Division of Drug Information
  • FDA Pharmacy Student Experiential Program

Teams

• Botanical Review Team
• Maternal Health Team