FDA Commissioner says agency embracing artificial intelligence to assist in scientific review, reduce burdens

Food and Drug Administration Commissioner Martin Makary says in prepared testimony at a Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies budget hearing for fiscal year 2026 that on day one of the job, an effort began to organize AI for scientific reviewers to make their jobs easier, with first AI assisted review announced two weeks prior where what normally took a reviewer two to three days the AI accomplished in six minutes, setting an aggressive goal of June 30 to have AI assisted scientific reviews help reviewers agency wide ahead of schedule and under budget.