Politico September 26, 2024
THE REGULATORS
The Food and Drug Administration plans to release new guidance on the use of artificial intelligence in pharmaceutical research.
The new recommendations, slated before the end of the year, follow a consolidation of three AI working groups into one council that will guide the agency’s AI policy work.
The guidance is based in part on responses the agency received to a 2023 discussion paper on the topic. The paper received more than 800 comments from 65 organizations, said Tala Fakhouri, the FDA’s associate director for data science and AI policy.
Between 2016 and 2022, the agency reviewed more than 500 drug submissions in which AI was used.
Fakhouri spoke with Ruth about how the agency is handling the...
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