US FDA centres to deploy AI internally, following experimental run

Generative AI tools will allow regulator to speed up review process

10 May 2025 - 10:10 By Puyaan Singh
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The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process, the regulator says. Stock photo.
The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process, the regulator says. Stock photo.
Image: 123RF

The US Food and Drug Administration (FDA) said on Thursday all its centres will deploy artificial intelligence (AI) internally immediately, with full integration on June 30, following the completion of a new generative AI pilot for scientific reviewers.

Once the FDA receives an application for the potential approval of a drug, it has six to 10 months to make a decision.

The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process, the regulator said.

"Future enhancements will focus on improving usability, expanding document integration and tailoring outputs to centre-specific needs, while maintaining strict information security and compliance with FDA policy," the regulator said.

On Wednesday Wired reported the drug regulator was in talks with OpenAI to discuss the use of AI, citing sources with knowledge of the meetings. The report added a small team from OpenAI had met with the FDA and two associates of Elon Musk's so-called department of government efficiency multiple times in recent weeks.

The agency will continue to assess performance, gather user feedback and refine features to support the evolving needs of its staff. Additional details and updates on the AI use will be shared publicly in June.

Reuters


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