Comment Letter on FDA's "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products"

The Duke-Robert J. Margolis, MD Institute for Health Policy (“Duke-Margolis” or the “Institute”) appreciates the opportunity to provide comments on the U.S. Food and Drug Administration’s (FDA) request: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. We are encouraged by the FDA’s commitment to advancing evidence generation including through the use of real-world data (RWD) and real-world evidence (RWE).

Read the comment letter here.