The FDA is set to implement AI tools across its centers following a successful generative AI pilot. This move aims to expedite the drug review process by automating repetitive tasks, although skepticism remains about AI's reliability. By June 30, the FDA plans to have all centers working on a unified AI system, despite an aggressive timeline. Talks with OpenAI indicate potential collaboration, although the announcement does not specify this. Historically, the FDA has explored AI's role in reviews, suggesting a foundation for this new initiative.
This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days.
By that date, all centers will be operating on a common, secure generative AI system integrated with FDA's internal data platforms.
The FDA sponsored a fellowship in 2023 to develop large language models for internal use.
It will be interesting to hear the details of which parts of the review were 'AI assist'.
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