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Medical Devices / Research and Development

Congress Pushes for In Silico Trials Modeling

July 18, 2017

The FDA already has plans to expand high-performance computing capabilities to simulate clinical trials, Commissioner Scott Gottlieb announced July 7, but the new focus on in silico clinical trials could soon be a congressional requirement.

In report language accompanying the fiscal 2018 appropriations bill, Congress would direct the FDA to expand its use of in silico clinical models through a pilot project aimed at “creation of a full human in silico model, able to test drugs and devices across the entire body, including long-term effects and among distinct populations.”

The agency should issue guidance to allow the model to be used to test both drugs and devices if necessary and the FDA would have to report back to appropriators within 120 days of the spending bill’s passage on development plans for the in silico model, the report says.

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