News & Insights


Real-World Evidence: The Evolving Landscape for FDA and EU Decision-Making About Drugs, Biologics, and Medical Devices

In response to the 21st Century Cures Act, the Food and Drug Administration (FDA) rapidly implemented a policy framework and separate guidance for drugs/biological products and medical devices addressing the use of real-world evidence (RWE) for regulatory decision-making. Because RWE has been used extensively for postmarket product safety analysis, this roundtable will focus on the evolving role of RWE in demonstrating clinical efficacy in premarket regulatory determinations. There continue to be challenges in the application of RWE for regulatory decision-making for novel product approval, clearance, and licensure. In addition, COVID-19-related disruption of traditional clinical trials and lessons learned from the Emergency Use Authorization of drugs and devices have accelerated the appreciation of opportunities for – as well as obstacles to – uses of RWE. This webinar will: 

  • Step through the FDA’s current RWE policy framework, including the distinction between real-world data (RWD) and RWE.

  • Discuss the explosive growth of sources of RWD and the agency’s evolving expectations regarding use of RWE (either alone or as a hybrid with traditional clinical trials) to support the analysis of efficacy of drugs and devices.  

  • Examine similarities and differences between the uses of RWE for drugs and devices and how RWE may arise in novel scenarios (e.g., interchangeability of biosimilar products; marketed regenerative medicine products now requiring approval due to the termination of enforcement discretion).   

  • Explore current challenges regarding use of electronic medical records for RWE.

  • Learn about use of RWD in European Union regulatory decisions compared with those in the U.S.

  • Address practical strategies for potential use of RWE for your premarket product and for navigating interactions with the FDA.

If you have questions concerning this roundtable webinar, email Chayako Williams at


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Event Details

Date: June 15, 2021

Time: 12:00 pm (ET)


Please register soon. You do not have to be a client to attend, and there is no charge.