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.
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.