Analyzing FDA's approaches to using electronic health record and medical claims data to support regulatory decision making

Abstract

In 2021, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of electronic health records and medical claims data for regulatory decisions. The draft guidance provides recommendations for sponsors regarding the use of real-world data in conducting studies. It also addresses the challenges and limitations associated with the use of these data and provides recommendations to overcome them. The purpose of this article is to provide a brief overview of key aspects of the FDA's guidance on the use of electronic health record data in regulatory decision making.