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

 
• By Ramsey Baghdadi

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

A novel FDA-approved indication for an existing drug can be supported by real-world evidence alone, but the sponsor still must meet the traditional evidentiary standard, Office of Medical Policy Associate Director for RWE John Concato reaffirmed.

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