The importance of RWD and RWE for FDA

This is the main topic addressed by FDA Commissioner Stephen Hahn during an all-hands first meeting with FDA staffers that has taken place last week.

Harness the power of data” is a clear statement that reveals the willingness to build a bridge with the work of his predecessor, Scott Gottlieb. This represents remarkable attention and concrete interest directed to improve the RWE’s use within FDA program.

“[…] we can improve our regulatory decision-making and more effectively connect today’s groundbreaking scientific discoveries with the rapid development and approval of new products. We can also increase the knowledge patients and consumers have to make informed decisions about FDA-regulated products”.
Hanh has offered a solution regarding this last topic: to build and expand the FDA’s Patient-Focused Drug Development initiative; by that consumers could be more informed on the lifecycle of products FDA regulates.

This intervention focused on the next challenging steps to unleash the power of data and “to attain more and better data”, especially considering how limited its FDA usage has been until now.