RWE-Only To Support A US FDA-Approved Indication? ‘Yes, Potentially’

CDER real world evidence policy head John Concato said the FDA could approve a new labeled use based only on real-world evidence, but made clear the approach is challenging. 

real world data
Using only RWE to gain a novel product approval will be challenging, FDA officials said. • Source: Shutterstock

More from Real-World Evidence

More from Clinical Trials