OpenAI is currently engaged in discussions with the U.S. Food and Drug Administration (FDA) regarding the use of artificial intelligence (AI) to improve and potentially accelerate the drug evaluation process.
Central to these conversations is a project known as cderGPT, an AI-powered tool designed to assist the FDA’s Center for Drug Evaluation and Research (CDER), which is responsible for regulating both prescription and over-the-counter medicines in the United States.
The talks have involved representatives from OpenAI as well as members of the Department of Government Efficiency (DOGE), a federal initiative linked to Elon Musk that focuses on modernising government operations through technological innovation.
The collaboration seeks to utilise AI’s capabilities to streamline parts of the drug approval timeline, which traditionally can extend beyond a decade due to the complexity of scientific research and regulatory requirements.
The FDA has recognised the increasing role of AI in various stages of drug development, including preclinical research, clinical trials, manufacturing, and post-market monitoring. In response, the agency published draft guidance in early 2025 titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products,” which provides a framework for the safe and effective integration of AI in regulatory processes.
To oversee AI-related activities within CDER, the FDA established the CDER AI Council in 2024. This body coordinates policy, technology, and regulatory efforts to ensure responsible use of AI while fostering innovation. It also aims to unify the FDA’s messaging on AI and align with broader federal strategies on artificial intelligence.
Despite the promise AI holds for expediting drug development and reducing delays, challenges remain. Concerns about the reliability, transparency, and potential biases of AI models persist, particularly when these tools influence critical decisions about drug safety and efficacy. The FDA’s approach reflects a careful balance between embracing innovation and safeguarding public health.
FDA Commissioner Marty Makary recently highlighted the agency’s commitment to modernising drug approvals through AI. “Why does it take over 10 years for a new drug to come to market? Why are we not modernized with AI and other things? We’ve just completed our first AI-assisted scientific review for a product and that’s just the beginning,” he stated.