Faster drug approvals possible as AI speeds FDA reviews

By Jeannie Baumann

The FDA is already laying the groundwork for using AI and machine learning—artificial intelligence that uses algorithms and statistical models to perform tasks and predict outcomes without being explicitly programmed—MIT researcher Pratik Shah said. The agency already has a real-world evidence framework and a plan to regulate software as a medical device.

“I think the FDA has done a really good job of actually being proactive and putting guidelines out,” Shah said.

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