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Industry Need FDA 'Engaged' Before Investing In Observational Studies

 
• By Sue Sutter

Developing general principles on use of observational data to support efficacy claims may be 'worthwhile,' CDER's Jarow acknowledges.

The pharmaceutical industry will invest in high-quality, methodologically rigorous observational studies to support drug efficacy if FDA spells out its regulatory expectations for such data, a Pfizer Inc. exec said at the Duke-Margolis Center for Health Policy meeting on real-world evidence.

"We need to call and inspire the FDA to get actively engaged in shaping the criteria for understanding what good credible evidence is," said Marc Berger, VP-real world

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