CDER Offices and Divisions

CDER Leadership Bios

Offices

• Office of the Center Director

  • Patient-Focused Drug Development Program Staff
  • Advisory Committee Staff 
  • Controlled Substances Program
  • Counter-Terrorism and Emergency Coordination Staff (CTECS)
  • Drug Shortages Staff

• Office of Communications

  • Division of Drug Information
    • FDA Pharmacy Student Experiential Program
  • Division of Health Communication
    • CDER Trade Press
  • Division of Digital and Online Communications
  • Professional Affairs and Stakeholders Engagement

• Office of Compliance

  • Office of Compounding Quality and 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

  • Immediate Office
  • Office of Bioequivalence
  • Office of Generic Drug Policy
  • Office of Regulatory Operations
  • Office of Research and Standards
  • Office of Safety and Clinical Evaluation

• Office of Management

• Office of Medical Policy

  • Office of Medical Policy Initiatives (OMPI)
  • Office of Prescription Drug Promotion Communications (OPDP)

• Office of New Drugs

  • Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN)
    • Division of Cardiology and Nephrology (DCN)
    • Division of Diabetes, Lipid Disorders and Obesity (DDLO)
    • Division of General Endocrinology (DGE)
    • Division of Division of Non-malignant Hematology (DNH)
    • Division of Pharm/Tox for Cardiology, Hematology, Endocrinology and Nephrology (DPT-CHEN)
  • Office of Drug Evaluation Sciences
    • Division of Clinical Outcome Assessment (DCOA)
      • Clinical Outcome Assessment (COA) Program Overview
      • Clinical Outcome Assessment (COA) Qualification Program: Frequently Asked Questions
• Division of Biomedical Informatics, Research, and Biomarker Development (DBIRBD)
  • Biomarker Qualification Program (BQP)
  • Biomedical Informatics and Regulatory Review Science (BIRRS)
  • OND Regulatory Science Research Program
• Digital Health Technology
• Drug Trials Snapshot
  • Office of Immunology and Inflammation (OII)
    • Division of Dermatology and Dentistry (DDD)
    • Division of Gastroenterology (DG)
    • Division of Hepatology and Nutrition (DHN)
    • Division of Pulmonology, Allergy and Critical Care (DPACC)
    • Division of Rheumatology and Transplant Medicine (DRTM)
    • Division of Pharm/Tox for Immunology and Inflammation (DPT-II)
  • Office of Infectious Diseases (OID)
    • Division of Anti-infectives (DAI)
    • Division of Antivirals (DAV)
    • Division of Pharm/Tox for Infectious Diseases (DPT-ID)
  • Office of Neuroscience (ON)
    • Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP)
    • Division of Neurology I (DN I)
    • Division of Neurology II (DN II)
    • Division of Pharm/Tox for Neuroscience (DPT-N)
    • Division of Psychiatry (DP)
  • Office of New Drugs Regulatory Science Research
  • Office of Nonprescription Drugs (ONPD)
    • Division of Nonprescription Drugs I (DNPD I)
    • Division of Nonprescription Drugs II (DNPD II)
  • Office of Oncologic Diseases (OOD)
  • Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM)
    • Division of Pediatrics and Maternal Health (DPMH)
    • Division of Rare Diseases and Medical Genetics (DRDMG)
    • Division of Urology, Obstetrics, and Gynecology (DUOG)
    • Division of Pharm/Tox for Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (DPT-RPRUMI)
  • Office of Specialty Medicine (OSM)
    • Division of Imaging and Radiation Medicine (DIRM)
    • Division of Ophthalmology (DO)
  • Office of Therapeutic Biologics and Biosimilars (OTBB)
  • Clinical Outcome Assessments (COA) Staff
  • Labeling Policy Team

• Office of Pharmaceutical Quality (OPQ)

  • Office of Policy for Pharmaceutical Quality
  • Office of Quality Surveillance
  • Office of Pharmaceutical Quality Research
  • Office of Quality Assurance
  • Office of Program and Regulatory Operations
  • Office of Product Quality Assessment I
  • Office of Product Quality Assessment II
  • Office of Product Quality Assessment III
  • Office of Pharmaceutical Manufacturing Assessment

• 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 
    • Division of Translational and Precision Medicine (DTPM)
    • Clinical Pharmacology Pediatrics Program
    • Therapeutic Biologics Program (TBP)
  • Office of Computational Science
  • Office of Study Integrity and Surveillance