OpenAI and the FDA are reportedly discussing AI for drug evaluations

OpenAI has met with officials from the U.S. Food and Drug Administration (FDA) to discuss the agency’s use of AI to speed up drug evaluations, Wired reported on Wednesday.
According to the report, OpenAI and the FDA have discussed a project called cderGPT, which seems to be an AI tool for the Center for Drug Evaluation (CDE). The CDE regulates over-the-counter and prescription drugs in the U.S. Associates from Elon Musk’s DOGE have reportedly been part of the talks as well.
It’s not uncommon for drug development processes to take more than a decade to complete. OpenAI’s work with the FDA aims to accelerate a small portion of that timeline, toward the end, per Wired. AI has long been touted as a potential accelerant that could be used throughout drug development, making some notoriously slow steps more efficient. That said, there are unanswered questions around how to control for the unreliability of AI models.
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