Drugmakers Get FDA Guidance for Submitting Real-World Data

Drugmakers on Thursday received insight on how they can transform real-world evidence into tangible data for studies supporting FDA product approval applications.

The Food and Drug Administration’s draft guidance includes recommendations on how to include these data sources in regulatory submissions in compliance with the Food, Drug and Cosmetic Act. Real-world data include indicators of a patient’s health status or the delivery of health care, gathered from electronic health records and billing activities, according to the FDA.

The updated recommendations are part of the FDA’s larger effort to evaluate the most effective use of real-world evidence in regulatory decision making. ...