AI Adds Complexities to Real-World Data in FDA Drug Approvals

Physician notes, medical images, and lab test results derived from electronic health records are increasingly making their way into the FDA’s drug and biologic approval or post approval process—largely due to AI.

“There is a huge appetite for high-quality real-world data and real-world evidence to support product applications,” said Nicholaas Honig, head of regulatory and senior counsel at Aetion. “There’s becoming a lot more of it, and sponsors are really thinking through how this can support approvals in a number of different ways.”

Real-world data, as described by the Food and Drug Administration, relates to the patient’s health status or ...