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Real-World Evidence Requires 'Leap Of Faith' For Industry, FDA – Gottlieb

 
• By Michael Cipriano

US FDA Commissioner says agency will soon offer more clarity on using real-world evidence in drug development, but notes industry needs to take risks of its own.

US FDA Commissioner Scott Gottlieb announced that the agency will be instituting regulatory clarity on the real-world evidence front, but also called on industry to take its chances in using such an approach in drug development.

"This takes a little bit of risk-taking on the part of sponsors who have to do something different in the face of a regulator who hasn't fully articulated what the standard would be," Gottlieb said at a National Academies of Sciences, Engineering, and

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