The FDA began accepting submissions in 2022 for a program to provide support for unconventional drug development tools that can assist, enhance and expedite new drug research. Finally in January 2024, it has accepted its first artificial intelligence-powered tool.
The program called Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot is designed to create a new pathway to FDA review novel tools that may not fit into currently existing routes of evaluation, but that could potentially improve the development of new drugs.
The newest tool accepted into ISTAND comes from Deliberate AI. The AI-generated Clinical Outcome Assessment—AI-COA for short—uses multimodal behavioral signal processing and machine learning technology to record mental health symptoms and assess the severity of cases of anxiety and depression.
“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,” Peter Stein, M.D., director of the Office of New Drugs within the FDA’s Center for Drug Evaluation and Research, said in an agency announcement this week. “Our acceptance aligns with FDA’s vision of optimizing drug development and evaluation, potentially expediting the availability of safe and effective treatments.”
Resources
FDA Announcement and Links to more info.