Infographic: What role does RWE play in FDA approvals?

The U.S. Food and Drug Administration (FDA) is approving more drugs with the help of real-world evidence (RWE) than ever before. In 2019, one in two of the agency’s approvals included an RWE study, and, according to our latest analysis, that number jumped to 75 percent in 2020.

In preparation for the FDA’s coming guidance on RWE, Aetion is assessing approval documents for New Drug Applications (NDAs) and Biologics License Applications (BLAs) to better understand the role of RWE in the agency’s decision-making.

In this infographic, we share a snapshot of that research, including how RWE informs prescribing, the therapeutic areas and submission types that most often use RWE, and key considerations for generating decision-grade evidence.