The U.S. Food and Drug Administration (FDA) is collaborating with OpenAI on a potential initiative called ‘cderGPT,’ aiming to leverage artificial intelligence (AI) for improved drug evaluation processes, according to ShibDaily. This initiative would bolster the FDA’s Center for Drug Evaluation and is part of a larger plan by Commissioner Martin A. Makary to significantly expand AI usage across all FDA operations by June 30th. The move reflects the FDA’s commitment to transforming drug evaluation and approval in the United States. However, concerns remain regarding how regulatory oversight will keep pace with rapid technological advancements. A pilot program testing this AI software has reportedly shown success, but comprehensive details about its scope, methodology, and findings are yet to be released. While assurances have been given that AI systems will adhere to strict information security protocols, specific details about the safeguards in place remain limited. The FDA maintains that AI is intended as a tool to augment human expertise, aiming to improve regulatory oversight through enhanced predictions of potential toxicity and adverse events. Ensuring public trust requires transparency, accountability, and clear communication as AI integration becomes more prominent across regulatory systems. Stakeholders across healthcare, technology, and government closely watch these developments to ensure innovation supports public safety and trust.