OpenAI and FDA Exploring AI for Drug Evaluation

2025-05-08

OpenAI recently met with officials from the U.S. Food and Drug Administration to discuss how the agency could leverage artificial intelligence to expedite the drug evaluation process.

Reports indicate that OpenAI and the FDA explored a project named cderGPT, which appears to be an AI tool designed for the Center for Drug Evaluation and Research (CDER). CDER oversees both over-the-counter and prescription medications in the United States. Notably, members of Elon Musk's DOGE team were also reportedly involved in these discussions.

The process of drug development often spans more than a decade, which is not uncommon. According to Wired magazine, the collaboration between OpenAI and the FDA aims to accelerate the later stages of this timeline. For years, artificial intelligence has been regarded as a potential solution to streamline various phases of drug development, particularly addressing some notoriously slow steps. Nevertheless, questions remain regarding how to manage the inherent unpredictability of AI models.