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

All are welcome to attend.