CDER Offices and Divisions

CDER Offices and Divisions

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Offices

• Office of the Center Director

  • Patient-Focused Drug Development Program Staff
  • Advisory Committee Staff 
  • Controlled Substance Staff
  • Counter-Terrorism and Emergency Coordination Staff (CTECS)
  • Professional Affairs and Stakeholders Engagement

• Office of Communications

  • Division of Drug Information
    • FDA Pharmacy Student Experiential Program
  • Division of Health Communications
    • CDER Trade Press
  • Division of Online Communications

• Office of Compliance

  • Office of Drug Security, Integrity and Response
  • Office of Manufacturing Quality
  • Office of Program and Regulatory Operations
  • Office of Scientific Investigations
  • Office of Unapproved Drugs and Labeling Compliance

• Office of Executive Programs

• Office of Generic Drugs

• Office of Management

• Office of Medical Policy

  • Office of Medical Policy Initiatives (OMPI)
  • Office of Prescription Drug Promotion (formerly Division of Drug Marketing, Advertising and Communications)

• Office of New Drugs

  • Office of Antimicrobial Products (OAP)
  • Office of Drug Evaluation I
    • Division of Cardiovascular and Renal Products (DCaRP)
    • Division of Neurology Products (DNP)
    • Division of Psychiatry Products (DPP)
  • Office of Drug Evaluation II
    • Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) 
    • Division of Metabolism and Endocrinology Products (DMEP)
    • Division of Pulmonary, Allergy, and Rheumatology Products (DPARP)
  • Office of Drug Evaluation III
    • Division of Dermatology and Dental Products
    • Division of Gastroenterology and Inborn Errors Products
    • Division of Bone, Reproductive and Urologic Products (DBRUP)
  • Office of Drug Evaluation IV
    • Division of Medical Imaging Products
      • Radioactive Drug Research Committee (RDRC) Program
    • Division of Nonprescription Drugs (DNDP)
    • Division of Pediatric and Maternal Health
  • Office of Hematology and Oncology Drug Products

• Office of Pharmaceutical Quality (OPQ)

• Office of Regulatory Policy

• Office of Strategic Programs

  • Office of Program and Strategic Analysis
  • Office of Business Informatics

• Office of Surveillance and Epidemiology

• Office of Translational Sciences

  • Office of Biostatistics
  • Office of Clinical Pharmacology
    • Division of Applied Regulatory Science
    • Division of Pharmacometrics 
    • Genomics and Targeted Therapy Group
  • Office of Computational Science
  • Office of Study Integrity and Surveillance

Teams

• Botanical Review Team
• Clinical Outcome Assessments Staff
• Labeling Development Team

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