FDA Explores AI Partnership with OpenAI to Accelerate Drug Approvals

The U.S. Food and Drug Administration (FDA) is in active discussions with OpenAI about integrating artificial intelligence into drug evaluation processes, Wired reported. The collaboration centers on “cderGPT,” a proposed AI system designed to assist the FDA’s Center for Drug Evaluation and Research.

FDA Commissioner Marty Makary recently emphasized the need to modernize the agency’s decade-long drug approval timeline, noting successful pilot tests of AI-assisted reviews. Jeremy Walsh, the FDA’s inaugural AI officer, leads the talks with OpenAI engineers, though no formal agreement exists yet.

While proponents argue AI could expedite application reviews and identify promising treatments faster, experts caution about risks like AI hallucinations in medical data analysis. The FDA currently uses fast-track pathways for urgent therapies but seeks AI to enhance precision in standard reviews.

OpenAI has simultaneously developed government-compliant tools like ChatGPT Gov, aiming for FedRAMP certification to handle sensitive health data. The initiative reflects growing federal interest in AI-driven regulatory innovation.