Office of Clinical Pharmacology Announces Reorganization

FDA Office of Clinical Pharmacology Reorganization Supports New Drugs Regulatory Program Modernization

On November 4, 2019, the U.S. Food and Drug Administration’s Office of Clinical Pharmacology (OCP) announced a major reorganization as a part of FDA’s Center for Drug Evaluation and Research (CDER) ongoing modernization efforts. In 2017, CDER embarked on a multi-phase regulatory improvement initiative to modernize the New Drugs Regulatory Program (NDRP). This initiative is comprised of structural changes, process and documentation improvements, and enhancements to administrative and regulatory operations, to advance public health goals. In support of these modernization efforts, OCP has consolidated cross-cutting functions and areas of regulatory evaluation for better review consistency and process efficiency through reorganization into the following therapeutically aligned divisions: Division of Infectious Disease Pharmacology (DIDP) - anti-infective and antiviral products Division of Cancer Pharmacology I (DCP I) – oncology, hematology, and medical imaging products Division of Cancer Pharmacology II (DCP II) – products for solid tumors Division of Neuropsychiatric Pharmacology (DNP) – neurology, psychiatry, anesthesia, analgesia, and addiction products Division of Cardiometabolic and Endocrine Pharmacology (DCEP) – reproduction, urology, general endocrinology, cardiovascular, nephrology, non-malignant hematology, diabetes, lipid disorders, and obesity products Division of Inflammation and Immune Pharmacology (DIIP) - pulmonary, allergy, rheumatology, gastroenterology, transplant, ophthalmology, dermatology, dentistry, critical care, and liver products Division of Translational and Precision Medicine (DTPM) - rare disease products, genomic tools and technologies, targeted therapies, and biomarkers Division of Pharmacometrics (DPM) - application of quantitative approaches that integrate drug pharmacology, disease pathophysiology, and clinical trial characteristics Division of Applied Regulatory Science (DARS) - applied research to develop novel standards, tools, and approaches OCP is committed to implementing issue-focused, interdisciplinary, team-based approaches to meet the challenges of evolving science, new drug platforms, and new drug targets, while incorporating the patient voice in development. This reorganization represents a critical step towards meeting the strategic objectives of CDER’s modernization initiative and achieving operational excellence. Additional details on the OCP reorganization can be found on OCP’s website at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-clinical-pharmacology. Further information on CDER’s initiative to modernization the NDRP can be found at https://www.fda.gov/drugs/regulatory-science-research-and-education/modernizing-fdas-new-drugs-regulatory-program. If you have specific questions, please contact ocp@fda.hhs.gov.