Posted by Michael Wonder on 24 Sep 2025
FDA use of real world evidence in regulatory decision-making
22 September 2025 - The FDA has a long history of using real world data and real-world evidence to monitor and evaluate the post-market safety of medical products and is committed to realising the full potential of fit for use real world data to generate real world evidence that can advance the development of medical products and strengthen their oversight.
The studies presented in the accompanying tables exemplify instances in which the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research applied real world evidence in regulatory decision-making processes since 2011.
