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  1. CDER Offices and Divisions

Office of Clinical Pharmacology

Who We Are

The Office of Clinical Pharmacology (OCP) is part of the Office of Translational Sciences (OTS). The mission of OCP is twofold: 1) play a pivotal role in advancing development of innovative new medicines by applying state-of-the-art scientific principles and 2) promote therapeutic optimization and individualization through best practices in research, policy development, and drug evaluation throughout the product lifecycle.

What We Do

  • Generate, evaluate, and use knowledge of drug disposition, pharmacology, and disease biology to progressively reduce regulatory uncertainty and inform public health decision-making
  • Employ mechanistic and model-informed drug development (MIDD) strategies to maximize the value of early and late phase clinical drug development
  • Use experimental and analytical approaches to identify, account for, and ultimately predict patient variability in drug responses
  • Promote therapeutic individualization and personalized medicine by translating knowledge of individual patient health characteristics into clinical recommendations for safe and effective drug use
  • Conduct research to address immediate and emerging regulatory science issues that impact the development, evaluation, and utilization of new therapeutic products

Office Organization

Office Director: Issam Zineh, Pharm.D., M.P.H.
Deputy Director: Shiew-Mei Huang, Ph.D.

Immediate Office (OCP-IO)

Division of Applied Regulatory Science (DARS)

Focuses on applied research to develop novel standards, tools, and approaches

Division of Cancer Pharmacology I (DCP I)

Focuses on the development and regulatory evaluation of:

  • Hematology Products
  • Oncology Products
  • Medical Imaging Products

Division of Cancer Pharmacology II (DCP II)

Focuses on the development and regulatory evaluation of oncology products for solid tumors

Division of Cardiometabolic and Endocrine Pharmacology (DCEP)

Focuses on the development and regulatory evaluation of:

  • Reproductive and urologic products
  • General endocrinology products
  • Cardiovascular and nephrology products
  • Non-malignant hematology products
  • Diabetes, lipid disorder, and obesity products

Division of Infectious Disease Pharmacology (DIDP)

Focuses on the development and regulatory evaluation of:

  •  Anti-infective products
  • Antiviral products
  • Animal Rule products

Division of Inflammation and Immune Pharmacology (DIIP)

Focuses on the development and regulatory evaluation of:

  • Pulmonary, allergy, and rheumatology products 
  • Gastroenterology products
  • Transplant products
  • Ophthalmology products
  • Dermatology and dental products
  • Critical care products
  • Liver products

Division of Neuropsychiatric Pharmacology (DNP)

Focuses on the development and regulatory evaluation of:

  • Neurology products
  • Psychiatric products
  • Anesthesia, analgesia and addiction products

Division of Pharmacometrics (DPM)

  • Applies quantitative clinical pharmacology approaches (i.e., model-informed drug development and quantitative medicine) to optimize trial design, dosing, patient selection, and streamline drug development across all therapeutic areas
  • Engages internal and external stakeholders to advance quantitative science for drug development and patient care

Division of Translational and Precision Medicine (DTPM)

Focuses on the development and regulatory evaluation of:

  • Rare disease/inborn errors of metabolism products
  • Genomic tools and technologies
  • Targeted therapies
  • Biomarkers

Contact Information

Office of Clinical Pharmacology
Office of Translational Science
Center for Drug Evaluation and Drug Research
U.S. Food & Drug Administration
Email: OCP@fda.hhs.gov.

OCP Reports



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