- OpenAI is in talks with the FDA to use AI for expediting parts of the drug evaluation process.
- The project being discussed is called cderGPT, aimed at assisting the Centre for Drug Evaluation.
OpenAI is reportedly in discussions with the U.S. Food and Drug Administration (FDA) to explore the use of artificial intelligence in drug evaluations, according to a Wired report published Wednesday.
These talks are said to focus on leveraging AI to expedite specific segments of the lengthy drug development process.
At the centre of the conversation is a project called cderGPT, which appears to be an AI tool intended for use by the FDA’s Centre for Drug Evaluation (CDE). This division is responsible for overseeing the regulation of both over-the-counter and prescription drugs in the United States.
Although still in the early stages, the initiative points to a broader interest in using AI to make regulatory reviews more efficient.
Reducing the Bottleneck
Drug development can often span over a decade, with bottlenecks commonly occurring in the evaluation and approval stages.
OpenAI’s collaboration with the FDA aims to potentially shorten the final leg of this process. While this wouldn't overhaul the entire development pipeline, any reduction in time could be significant for pharmaceutical companies and patients alike.
Associates from Elon Musk’s DOGE have also reportedly been part of these discussions, indicating that the interest in applying AI to healthcare evaluation may be drawing attention from a wide range of players in the tech space.
Despite the enthusiasm, concerns remain about the reliability and control mechanisms of AI models in high-stakes fields like drug approval.
While AI has long been viewed as a potential game-changer in healthcare, regulators are likely to move cautiously to ensure safety and accountability.
Edited by Annette George
