FDA eliminates major barrier to using real-world evidence in reviews

The US Food and Drug Administration (FDA) yesterday removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews.

In new guidance for certain types of medical device submissions, the agency states it will accept RWE without requiring that identifiable individual patient data collected from real-world data sources always be submitted in a marketing submission. The FDA similarly intends to consider updating its guidance for drugs and biologics.

While RWE has been promoted as an advance in regulatory policy, past agency expectations have meant that most RWE could not be considered in product applications. Since 2016, 35 drugs, biologics, or vaccines have included RWE in their applications. The integration of RWE into device approvals has been more extensive, with over 250 premarket authorizations including RWE for the same period, although even for devices the rate of RWE-based authorizations has plateaued in recent years.