This presentation will review FDA’s RWE program framework, a multifaceted framework that will evaluate the potential use of RWE in regulatory decisions. The presentation will highlight the key elements of the program, including internal and external deliverables. A review of ongoing demonstration projects and their role in informing policy development will be covered.
Jacqueline Corrigan-Curay, J.D., M.D., serves as Director of CDER’s Office of Medical Policy (OMP) at the FDA. 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.
Prior to joining FDA, she served as supervisory medical officer with the Immediate Office of the Director, National Heart, Lung and Blood Institute (NHLBI), at National Institute of Health’s (NIH) where she focused on developing policies and procedures to enhance the clinical trial enterprise. She also served as the Director of the Office of Biotechnology Activities (OBA), Office of Science Policy at NIH, where she was executive secretary of the NIH Recombinant DNA Advisory Committee. She has held positions as an attending physician with the VA Medical Center, a policy analyst with the Congressional Office of Technology Assessment, and a practicing attorney in Washington, D.C.
Dr. Corrigan-Curay earned her law degree from Harvard Law School, her medical degree from University of Maryland School of Medicine, and a bachelor’s degree in history of science from Harvard/Radcliffe College in Cambridge, MA. She completed her training in internal medicine at Georgetown University Medical Center, where she also served as a clinical assistant professor of medicine. She continues to practice internal medicine part-time at the Veterans Affairs Medical Center in Washington, D.C.