The US Food and Drug Administration (FDA) has set an “aggressive” timeline to implement generative artificial intelligence (genAI) across the agency by 30 June 2025.
According to the agency, the technology has amply demonstrated its value in enabling FDA personnel to spend less time on 鈥渢edious, repetitive tasks that often slow down the review process鈥�.
The news follows a pilot of genAI鈥檚 application in scientific review tasks.
FDA commissioner Dr Martin Makary said he was 鈥渂lown away鈥� by the agency鈥檚 first genAI-assisted scientific pilot review.
He commented: 鈥淲e need to value our scientists鈥� time and reduce the amount of non-productive busywork that has historically consumed much of the review process.
鈥淭he agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.鈥�
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By GlobalDataDr Makary has directed all FDA centres to begin deployment immediately, with the goal of 鈥榝ull integration鈥� by the end of June to accelerate genAI adoption.
While not all details of the genAI transformation plans were immediately clear, it is understood that work will continue to 鈥渆xpand use cases, improve functionality and adapt to the evolving needs of each centre鈥� after June 30, but by this date, all centres are required to be operating on a 鈥済enAI system鈥� integrated with the FDA鈥檚 internal data platforms.
The genAI rollout efforts are being coordinated by Jeremy Walsh, the FDA鈥檚 newly appointed chief AI officer.
Dr Makary continued: 鈥淭here have been years of talk about AI capabilities in frameworks, conferences and panels, but we cannot afford to keep talking. It is time to take action.鈥�
Under the leadership of Health and Human Services (HHS) Secretary Robert F Kennedy, Jr (RFK Jr), the combined workforce of US health agencies such as the FDA and the Centers for Disease Control and Prevention (CDC) has been reduced from .
During a webinar hosted by last month, Dr Jeff Shuren, who served as director of the FDA鈥檚 Center for Devices and Radiological Health (CDRH) from 2009 until July 2024, said it would 鈥渘ot be surprising鈥� if the cuts resulted in longer device review times at the FDA, at least in the near term.
鈥淥ne of the challenges moving forward will be to assure that the FDA鈥檚 premarket review programme has the expertise that it needs, and that time and attention is put into recruitment and retention,鈥� said Shuren.
While the introduction of genAI at the FDA offers potential benefits, it remains uncertain whether the technology can fully compensate for the reduction in staff under RFK Jr鈥檚 leadership.
