RWE is playing a growing role in FDA approvals. According to an Aetion analysis, 49 percent of submissions for new drugs and biologics in 2019 included an RWE study. In 2020, that figure jumped to 75 percent.
In Aetion’s growing library of FDA Decision Alerts, they share examples in which RWE was used in the submission package for NDAs and BLAs. Visit the FDA Decision Alerts page to see additional summaries; then Aetion will send you alerts as they add more to the site.