Who We Are:
The Office of Medical Policy (OMP) leads the development, coordination, and implementation of medical policy programs and strategic initiatives. OMP works collaboratively with other CDER program areas, FDA centers, and stakeholders to enhance policies to improve drug development and regulatory review processes. OMP is comprised of the Office of Medical Policy Initiatives and the Office of Prescription Drug Promotion.
What We Do:
- Provide Center oversight and leadership in the development of medical policy, procedures, and policy initiatives pertaining to drug development, drug approval, bioresearch monitoring, human subject protection, post market surveillance processes, and the science and efficiency of clinical trials.
- Provide scientific and regulatory leadership in ensuring accurate and effective communication of medical information to health care professionals and patients in compliance with applicable regulations.
- Foster an interdisciplinary approach to medical policy development, implementation, and coordination through collaboration with other disciplines, program areas, FDA Centers, and stakeholders in a manner that enhances integration of evolving science and policy into drug development, regulatory review, and post market surveillance processes.
- Provide guidance and policy development regarding prescription drug promotion and review prescription drug advertising and promotional labeling to ensure that the information contained in the material is not false or misleading.
- Office of Medical Policy Immediate Office
- Office of Medical Policy Initiatives
- Office of Prescription Drug Promotion
Email: CDEROMP@fda.hhs.gov | Phone: 301-796-2500 | Fax: 301-847-3529
Office of Medical Policy, 10903 New Hampshire Avenue, Building 51, Silver Spring, MD 20993