Officials from OpenAI and the U.S. Food and Drug Administration (FDA) have reportedly entered discussions about utilizing artificial intelligence technology to expedite the process of drug evaluations. A reported collaboration known as “cderGPT,” presumably referring to an AI system designed specifically for the agency’s Center for Drug Evaluation, is at the core of these discussions. The FDA’s Center for Drug Evaluation oversees regulatory review of prescription and over-the-counter medications in the United States.
Associates affiliated with DOGE, Elon Musk’s venture, have also reportedly participated in the talks, though the extent of their involvement has not been made clear. The collaboration signals increasing interest among regulators and technology companies in accelerating drug assessments—an often painstakingly lengthy process that can traditionally span more than a decade.
AI has frequently been highlighted as a powerful tool capable of optimizing numerous stages within the drug-development pipeline, especially targeting some of its slowest and most tedious steps. However, experts continue to voice concerns about AI’s reliability, stressing that significant questions remain regarding potential inaccuracies and unpredictabilities that could emerge from relying on machine-driven models for crucial regulatory decisions.
