Mobile Device Data Could Speed Drug, Device Approvals: FDA

Discussion of using real-world data for drug and device regulation should shift to patient-focused data sources like Apple watches, tracking devices, and other mobile technologies, an FDA medical policy leader said.

“It may just be easier to tell your smartphone you didn’t take your medication, or you took something that your doctor might not like,” said Jacqueline Corrigan-Curay, medical policy director in the Food and Drug Administration’s drug center.

The adoption of real-world evidence is a push to make FDA medical product approvals more efficient by harnessing the explosive growth in health data to look for patterns that could ...