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USFDA's ISTAND Pilot Program: Accepts First Submission of AI-Based Digital Tech for Neuroscience

A new submission has been accepted into the FDA's Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

Drug Development Tools (DDTs) are methods, materials, or measures that have the potential to facilitate drug development. The ISTAND initiative, launched in 2020, is designed to facilitate the development of novel drug development tools (DDTs) for use in regulatory applications of new medical products. Program participants are able to evaluate and apply DDTs that do not fit into established pathways, such as biomarkers and clinical outcomes.

FDA accepted this letter of intent (LOI), received on October 13, 2021 (and revised on April 2, 2023), has been reviewed by FDA. In the accepted letter of intent (LOI), a machine learning (ML) model is used 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, as well as multiple behavioral and physiological indices of depression.

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 specific drug development need, the availability of information and resources supporting the proposed qualification effort, as well as the demonstration that the DDT is feasible and practicable within the proposed context.

FDA will now work with the applicant to provide feedback on the next qualification step—a qualification plan. In preparing to submit a Qualification Plan (QP), the applicant has to address each of the specific considerations and recommendations and any data requests in the body of the QP.

The acceptance of the first AI-based and digital health technology for neuroscience under the ISTAND Pilot Program marks a significant milestone in the convergence of technology and healthcare and the FDA believes that leveraging AI and digital health tools will enhance the efficiency, accuracy, and predictability of drug development and evaluation processes, particularly in the realm of neuroscience.

More information on the accepted ISTAND submissions can be found in the CDER & CBER Drug Development Tool Qualification Project Search database.


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