FDA's Embrace of AI to Speed Up Drug Approvals Leaves Industry Observers Excited, Uneasy

Under pressure to speed up the review of drugs and medical devices, the Food and Drug Administration is turning to artificial intelligence tools to help its scientific reviewers and investigators aggressively shorten the process.

But the move, rolled out in two announcements in recent weeks, is raising a host of questions on whether AI will make scientific conclusions about the safety and effectiveness of drugs and devices or will be limited to summarizing information and other administrative tasks.