Advancing Real-World Evidence in FDA Regulatory Decision Making
Moderator
Marie Bradley, FDA, Silver Spring, MD, United States
Speakers
Motiur Rahman, MS, PhD, US Food and Drug Administration, Silver Spring, MD, United States; Joel Weissfeld, MPH, MD, US Food and Drug Administration, Silver Spring, MD, United States; Shirley Wang, PhD, Brigham & Women's Hospital, Harvard Medical School, Boston, MA, United States
Purpose: The FDA Center for Drug Evaluation and Research regulates drug products and has a program for the evaluation of real-world data (RWD) to generate real-world evidence (RWE) for regulatory decision-making. This workshop offers a forum for sharing key activities and accomplishments of FDA’s RWE program with ISPOR attendees. The session will showcase topics of broad interest to ISPOR membership, including recent approvals that involved RWE, FDA funded research projects, new Agency-level RWE initiatives, and ongoing efforts to advance RWE policy to support regulatory decision-making. This aligns with ISPOR’s interest in using RWE to inform healthcare decisions. Description: Workshop participants will learn how FDA determines whether RWD are fit-for-use, study designs provide adequate scientific evidence, and study conduct meets regulatory requirements. They will be able to summarize key messages from FDA RWE guidance documents and explain how FDA-supported RWE research projects have addressed gaps in knowledge to support medical product development. Dr Bradley will chair the session and provide a brief overview of RWE-related activities of the FDA RWE program. Drs. Rahman and Weissfeld will cover notable RWE-based product approvals, draft and final RWE guidance documents, and selected RWE-related demonstration projects. Prof. Shirley Wang will provide perspective as an FDA funded collaborator on efforts in advancing the use of RWE in regulatory decision making.
Topic
Epidemiology & Public Health, Health Policy & Regulatory, Real World Data & Information Systems