FDA Removes Significant Barrier to Using Real-World Evidence in Product Submissions

The U.S. Food and Drug Administration announced a major shift in its approach to real‑world evidence (RWE). In new guidance for certain medical device submissions, FDA will accept RWE without always requiring identifiable, patient‑level data collected from real‑world data (RWD) sources to be submitted in the marketing application. FDA also signaled its intent to consider updating guidance for drugs and biologics to reflect a similar policy. Reviewers will evaluate the strength and suitability of…
By: Orrick, Herrington & Sutcliffe LLP