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 FDA | CDER | Small Business and Industry Assistance
INDUSTRY NEWS
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The Food and Drug Administration's Innovative Science and Technology Approaches for New Drugs (ISTAND) program has accepted a letter of intent (LOI) for a wearable sensor-derived digital outcome measure intended to quantify foot drop severity and its impact on gait in adult patients with Charcot-Marie-Tooth disease type 1A (CMT1A), a progressive, degenerative disease. This LOI represents the first submission to be accepted into the ISTAND program for a digital health technology (DHT) for a rare neurological condition.
This LOI represents both a DHT and a novel approach to outcome measurement in neuromuscular drug development, both important areas of focus for CDER.
Launched in 2020, the ISTAND program aims to support the development of novel DDTs for use in regulatory applications for new medical products, particularly tools that do not readily fit into established qualification pathways, such as those for biomarkers and clinical outcome assessments. The program opens opportunities for DDTs that address specific drug development needs and demonstrate feasibility and scientific merit. The LOI acceptance 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 supporting information and resources, and the feasibility and practicality of implementation.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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