Posted by Michael Wonder on 17 Dec 2025
FDA eliminates major barrier to using real world evidence in drug and device application reviews
15 December 2025 - The US FDA today removed a key limitation on the use of real world evidence used in drug and device applications reviews.
In new guidance for certain types of medical device submissions, the agency states it will accept real world evidence 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.
