Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products – Looking Forward

Meeting Objective:

To provide an update, as well as to solicit input from interested parties, on current and future activities of the U.S. Food and Drug Administration (FDA)'s Real-World Evidence (RWE) Program for drugs and biological products.

At the end of this meeting, participants will better understand:

• FDA’s approach to RWE for regulatory decision-making
• ongoing opportunities and challenges regarding RWE
• future initiatives for promoting the appropriate use of RWE

This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $700,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.