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STAT+: FDA plans to begin rolling out AI tool agency-wide on Tuesday
The FDA plans to roll out its agency-wide AI tool weeks ahead of schedule, per a press release that provides the most detailed look yet at the technology and how…
The Food and Drug Administration plans to roll out its agency-wide AI tool on Tuesday, weeks ahead of schedule, according to a press release obtained by STAT that provides the most detailed look yet at the technology and how it may be used.
Commissioner Marty Makary has hailed the potential of the AI at the FDA, saying it could save employees time and ultimately speed up regulatory reviews. “When I announced earlier this month that I was launching an aggressive AI timeline for the agency, I meant it,” he says in the draft release.
At the same time, speaking to STAT, FDA employees characterized the launch of the AI, called Elsa, as “rushed” and expressed concern the agency is both over-inflating its capabilities and failing to set guardrails. Makary announced only in May that the rollout would be expedited, with expectations that it would be done by June 30.
