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4 min read Regulatory

Watchdog Wednesday: US FDA’s AI Trial Revolution Gets Rescheduled

The AI trial pilot survived its own architects' departure. For one more month, the docket is where it gets decided.

Watchdog Wednesday: US FDA’s AI Trial Revolution Gets Rescheduled
Regulators need to collect a few more comments before transforming clinical trials.

We now know something of the fate of one of former FDA Commissioner Martin Makary’s signature initiatives: the pilot to let artificial intelligence optimize early-phase clinical trials has been delayed. When the project was unveiled on April 28, the agency had laid out an ambitious timetable: The public had until the end of May to comment, the agency would announce selection criteria by July, and the companies participating would be unveiled in August.