electronic health records

FDA Framework for Use of Real-World Evidence



The U.S. Food and Drug Administration (FDA) released a Framework in December 2018 for the use of real-world evidence, which is not routinely collected during the course of a clinical trial. Under the 21st Century Cures Act, the FDA was to establish a program to evaluate the use of real-world evidence to help support a new indication for an approved drug or to satisfy post approval requirements. RWE evidence has been used by the FDA for some time to monitor drug safety, but its use to determine effectiveness has been limited.