Office of Clinical Pharmacology
Mission
- Advancing development of innovative new medicines by applying state-of-the-art scientific principles.
- Promoting therapeutic optimization and individualization through best practices in research, policy development, and drug evaluation throughout the product lifecycle.
Vision
- Improve public health by building and translating knowledge of drug-response into patient-centered regulatory decisions of the highest quality.
Our Organization
The Office of Clinical Pharmacology (OCP) is a multidisciplinary organization within the FDA's Center for Drug Evaluation and Research (CDER) Office of Translational Sciences that applies clinical pharmacology principles to patient-centered regulatory decisions. Guided by core values of stewardship, leadership, excellence, connectedness, and respect, OCP leverages its multidisciplinary expertise and collaborative partnerships to improve patient health outcomes through evidence-based regulatory decision-making.
Focus areas for the immediate office and divisions in OCP are listed below:
- Immediate Office: clinical pharmacology programs and project management that encompass all divisions
- Division of Applied Regulatory Science (DARS): applied research to develop novel standards, tools, and approaches
- Division of Cardiometabolic and Endocrine Pharmacology (DCEP): cardiology, nephrology, hematology, diabetes, lipid disorders, obesity, general endocrinology, urology, and obstetrics/gynecology
- Division of Cancer Pharmacology I (DCPI): hematological malignancies and medical imaging
- Division of Cancer Pharmacology II (DCPII): oncology
- Division of Infectious Disease Pharmacology (DIDP): anti-infectives, antivirals, and products developed under the Animal Rule
- Division of Inflammation and Immune Pharmacology (DIIP): rheumatology, transplant, pulmonary, allergy, critical care, gastrointestinal, liver, dermatology, dentistry, and ophthalmology
- Division of Neuropsychiatric Pharmacology (DNP): neurology, psychiatry, anesthesia, addiction, and analgesics
- Division of Pharmacometrics (DPM): model-informed drug development and quantitative medicine
- Division of Translational and Precision Medicine (DTPM): rare diseases/inborn errors of metabolism, genomics, targeted therapies, and biomarker qualification
Connect With Us
Key Initiatives
OCP's regulatory science research program develops innovative tools, standards, and approaches for evidence-based decision-making by applying clinical pharmacology and translational medicine principles to ensure drug and biologic product safety, efficacy, and quality. OCP maintains a robust research portfolio using state-of-the-art analytical, laboratory, computational, and translational methods including artificial intelligence/machine learning, in vitro systems, and clinical studies to address public health challenges. The Division of Applied Regulatory Science (DARS) contains multidisciplinary teams conducting mission-critical research for regulatory decision-making.
Contact: DARS Main
Resource: Division of Applied Regulatory Science
Biological and biosimilar products have unique pharmacological considerations, analytical requirements, treatment applications. To facilitate their development and approval, OCP formed the Therapeutic Biologics Program (TBP). TBP includes experts with both knowledge of clinical pharmacology and experience in biological and biosimilar products who perform specialized review, policy development, and research.
Contact: TBP Main
Resource: Therapeutic Biologics Program
Patients frequently use several drugs at a time. Drug-drug interactions (DDIs) can occur when a co-administered drug alters the systemic exposure of another drug. These changes could result in reduced efficacy or increased adverse reactions. OCP carefully evaluates the risk of DDIs to assess the benefit-risk profile of a new drug prior to market approval.
Contact: DDI Main
Resources:
- Drug Interactions & Labeling
- FDA’s Examples of Drugs that Interact with CYP Enzymes and Transporter Systems
The Fit-For-Purpose (FFP) Initiative is a pathway for regulatory acceptance of evolving drug development tools which do not go through other Agency qualification programs. When a tool receives FFP designation, it means FDA has evaluated it and determined it to be suitable for use in the drug development context outlined in the FFP Determination Letter. The determination letter is made public to encourage wider use of these tools.
Contact: FFP Main
Resource: Fit-for-Purpose Initiative
The FDA's Model-Informed Drug Development (MIDD) Paired Meeting Program supports the use of quantitative modeling methods from preclinical and clinical data to help balance drug risks and benefits, improve clinical trial efficiency, and optimize dosing without requiring dedicated trials. The program allows selected sponsors to meet with FDA staff to discuss how to apply these MIDD approaches in their medical product development.
Contact: MIDD Main
Resource: Model-Informed Drug Development Paired Meeting Program
OCP advances new approach methodologies (NAMs), including complex in vitro models and computational tools, to support regulatory decision-making across therapeutic areas, improve translational relevance, strengthen safety and efficacy assessments, and reduce reliance on animal testing. To further align these efforts, CDER has established a NAMs Coordinating Committee to serve as a central point of contact for CDER and external stakeholders, promote consistency in NAMs evaluation, facilitate knowledge sharing, and accelerate the appropriate integration of NAMs into drug development and regulatory decisions. OCP partners with other FDA offices and external institutions to advance FDA's commitment to reducing reliance on animal testing for drug safety assessments.
Contact: NAMs Main
Several factors make drug development and dosing unique in pediatric patients, including physiological differences that impact how they process drugs. OCP established a dedicated team of experts in pediatric clinical pharmacology and health sciences to advance the development of drugs in this population through review, stakeholder engagement, policy, and education. Encouraging research in critical new areas, such as pediatric developmental safety assessment for new drugs and maternal-fetal care, is an essential activity for the group.
Contact: Pediatrics Main
Resource: Clinical Pharmacology Pediatrics Program
OCP ensures clinical pharmacology principles and precision medicine strategies are properly applied throughout drug development to maximize patient benefits and minimize risks. The Division of Translational and Precision Medicine (DTPM) focuses on integrating genomics, advancing targeted therapies, supporting biomarker qualification, and leveraging clinical pharmacology data for rare disease therapeutics through regulatory review, science, policy development, and educational outreach. DTPM also contributes their expertise to CDER’s Accelerating Rare disease Cures (ARC) Program.
Contact: DTPM Main
Resources:
- Table of Pharmacogenomic Biomarkers in Drug Labeling
- Division of Translational and Precision Medicine (DTPM)
- Accelerating Rare disease Cures (ARC) Program
Pharmacometrics is the science of quantifying drug, disease, and trial information to aid in efficient drug development and regulatory decisions. OCP develops, validates, and reviews models to evaluate the impact of drug concentration, dose, and population variabilities based on intrinsic and extrinsic factors to ensure that medications are safe and effective. OCP’s Division of Pharmacometrics (DPM) is a multidisciplinary team consisting of quantitative clinical pharmacologists, statisticians, engineers, and data management experts who work closely with clinicians and statisticians to apply models to the regulatory review process.
Contact: DPM Main
Resource: Division of Pharmacometrics
The CDER Quantitative Medicine (QM) Center of Excellence (CoE) coordinates and advances the consistent application of quantitative medicine approaches across CDER for drug development and regulatory decision-making. The QM CoE functions as a CDER-wide coordinating body that promotes collaboration, innovation, and integration of quantitative medicine to enhance therapeutic product development and regulatory decisions while advancing public health.
Contact: QM CoE Main
Resource: CDER Quantitative Medicine Center of Excellence (QM CoE)
Newsletter: Subscribe to Quantitative Medicine (QM), including Model-Informed Drug Development (MIDD) newsletter
OCP's regulatory evaluation process uses a multidisciplinary, issue-based strategy to ensure approved drugs and biologics are administered at the right doses to the right patients at the right time. Through comprehensive reviews of investigational new drug (IND) submissions, new drug applications (NDAs), and biologic license applications (BLAs), OCP addresses dose selection and optimization, therapeutic individualization, and benefit/risk balance while identifying knowledge gaps and recommending studies to address them.
Contact: OCP Main
OCP maintains multifaceted connections with internal and external partners through various communication channels including in-person meetings, virtual platforms, professional society meetings, and web-based media to share regulatory perspectives and scientific advances.
Clinical Pharmacology Corner Newsletter
The Clinical Pharmacology Corner is a free newsletter service from FDA that provides occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today!
Workshops: Want to view a past conference or register for an upcoming meeting? Visit CDER's Meetings, Conferences, & Workshops web page for more information.
Recent Publications: 2025 Office of Clinical Pharmacology publications