Exclusive Interview

FDA Aims To Speed Clinical Trials, Improve Device Safety Through Post-Market Evaluation, But Funding A Hurdle

February 16, 2016 at 11:56 AM
FDA's device center chief Jeff Shuren, in an interview with Inside Health Policy , highlighted the benefit a robust National Device Evaluation System could have in bolstering the agency's ability to monitor devices in real-time to better inform the risk-benefit profile of approved products. Such a system, he said, could also help in the premarket approval phase to reduce the clinical trial burden on manufacturers and get products to market faster. The program is a high priority for the Center...


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