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  1. Drug Safety and Availability

FDA's ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience

[1/23/2024] FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) recently accepted a new submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. This submission is the first artificial intelligence-based and digital health technology-based project and the first project in neuroscience to be accepted into ISTAND.

“This marks a pioneering step for the ISTAND program as the first artificial intelligence-based, digital health technology project in neuroscience to be accepted into the pilot program,” said Peter Stein, M.D., director of CDER’s Office of New Drugs. “Our acceptance aligns with FDA's vision of optimizing drug development and evaluation, potentially expediting the availability of safe and effective treatments.”

Launched in 2020, ISTAND aims to support the development of novel drug development tools (DDTs) to be used in regulatory applications for new medical products. The program opens opportunities for DDTs that do not fit into established pathways for evaluation and application such as for biomarkers and clinical outcome assessments.

The accepted letter of intent (LOI) 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 (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) scores. This LOI represents both a digital health technology (DHT) and artificial intelligence (AI)/ML, both important areas of focus for FDA.

The LOI acceptance is the first step of the three-step qualification process in the DDT qualification programs, and it is based on several factors, including the scientific merit of the submission, the ability of the DDT to address a specified drug development need, the availability of information and resources that support the proposed qualification effort and demonstration that the DDT is feasible and practical within the proposed context of use. FDA will now work with the applicant to provide feedback on the next qualification step—a qualification plan.

FDA continues to foster innovative solutions in drug development, including AI/ML and DHTs, as outlined in recent publications to include “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products”, “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development,” and the recent final guidance, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.”

CDER and CBER are excited to advance the future of innovative DDT development with the first AI and DHT acceptance into the pilot program. We eagerly anticipate ISTAND’s role in advancing novel approaches to drug development and its contribution to bringing effective therapies to patients faster and more efficiently.

Find additional accepted ISTAND submissions in the CDER & CBER Drug Development Tool Qualification Project Search database.

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