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# 1st ISTAND Pilot AI Submission Accepted
- URL: https://www.fdaweb.com/1st-istand-pilot-ai-submission-accepted/
- Published: 2024-01-24T12:00:00.000Z
- Updated: 2026-09-14T14:21:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156198

CDER and CBER have accepted the first artificial intelligence-based and digital health technology-based project and the first project in neuroscience in the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program. An agency [statement](https://www.fda.gov/drugs/drug-safety-and-availability/fdas-istand-pilot-program-accepts-submission-first-artificial-intelligence-based-and-digital-health?ref=fdaweb.com) says the accepted letter of intent submission is for an automated depression and anxiety severity measurement tool utilizing multiple behavioral and physiological indices of depression in a machine learning (ML) model to derive clinician-reported outcomes for depression and anxiety based on the Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale scores.

The letter of intent acceptance is the first in a three-step qualification process in the drug development tool program, FDA says, and is based on factors such as the project’s scientific merit, the ability of the drug development tool to address a specified drug development need, the availability of information and resources that support the proposed qualification effort, and demonstration that the drug development tool is feasible and practical within the proposed context of use.

The agency says it will now work with the applicant to provide feedback on the next qualification step, a qualification plan.

Started in 2020, ISTAND is meant to support the development of novel drug development tools to be used in regulatory applications for new medical products, the notice says. It says the program opens opportunities for tools that do not fit into established pathways for evaluation and application such as for biomarkers and clinical outcome assessments.