CAPT Denise Hinton serves as Acting Director of CDER’s Office of Medical Policy (OMP). She leads the development, coordination, and implementation of medical policy programs and strategic initiatives. She works collaboratively with other CDER program areas, FDA centers, and stakeholders on enhancing policies to improve drug development and regulatory review processes.
OMP is comprised of the Office of Prescription Drug Promotion (OPDP) and the Office of Medical Policy Initiatives (OMPI). OPDP oversees the regulation of prescription drug promotion and advertising. OMPI provides oversight and direction for new and ongoing policy initiatives in broad-based medical and clinical policy areas.
In 2013, CAPT Hinton assumed the duties of Deputy Director, OMP. Prior to this role, she served as Director in the Office of Medical Policy Initiatives. She provided oversight and direction for the development of medical policies and procedures related to drug development and drug approval processes, bioresearch monitoring, and human subject protection. These areas include initiatives to improve the science and efficiency of clinical trials, and to enhance professional and patient labeling for prescription drugs.
CAPT Hinton began her career with FDA in 2002 in CDER’s Division of Cardiovascular and Renal Products and later in the former Division of Training and Development. Before coming to FDA, CAPT Hinton served as an officer in the U.S. Air Force. She received a bachelor of science degree in nursing from Florida State University and a master of science degree from Boston University.