FDA Prepares to Bolster Data Use in Drug, Device Approvals

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 ...