FDA guidance opens the door to de-identified real-world evidence in regulatory submissions A policy update removes a longstanding barrier for medical device sponsors and signals a broader shift that could eventually reshape how drug and biologic developers approach evidence generation. Written byAndrea Corona

https://www.drugdiscoverynews.com/fda-guidance-opens-the-door-to-de-identified-real-world-evidence-in-regulatory-submissions-17173 For years, one of the practical limits on using real-world evidence in regulatory submissions was a straightforward data access problem: the FDA expected sponsors to submit individually identifiable patient-level data when incorporating real-world data (RWD) into applications, which made it difficult to draw on the large, de-identified datasets that have become increasingly central to clinical research.