The Food and Drug Administration (FDA) ISTAND Pilot Program Accepts Submission of First AI-Based Technology for Neuroscience

January 23, 2024

United StatesU.S. Executive Branch

Summary

The FDA’s Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program is designed to encourage the use of innovative methods, materials or measures that have the potential to facilitate drug development in a specified area of need. The agency’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) accepted the first AI-based, digital health technology project in neuroscience. This tool utilizes multiple behavioral and physiological indices of depression and anxiety in a machine learning model to derive severity measurements.

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