While regulatory science can lag behind technology advances, the FDA has for the past few years been exploring ways to harness the potential of artificial intelligence (AI) to streamline drug development and the approval process. A nexus for its efforts is the Information Exchange and Data Transformation (INFORMED) initiative anchored in the agency's Oncology Center of Excellence (OCE). At its inception in 2016, INFORMED was designed to tap into the power of big data and advanced analytics to improve disease outcomes.