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FDA Prepares to Bolster Data Use in Drug, Device Approvals

Sept. 12, 2019, 11:00 AM

An FDA plan to turbocharge its use of patient data to review drugs and medical devices will be the first of a series of actions that make better use of artificial intelligence, blockchain, and other new technologies for approval decisions, the agency’s second-in-command tells Bloomberg Law. The plan is expected to be released in the coming weeks.

Quicker Turnaround: The modernization effort aims to allow the Food and Drug Administration to more quickly evaluate applications, which will enable manufacturers to bring products to market faster.

Brave New World: New technology that relies on patient data brings challenges as well as ...