Data-Sharing, AI, Collaboration Prioritized in FDA IT Modernization Plan

The FDA’s plan to modernize its IT infrastructure features several improvements that will benefit clinical trials and sponsors, including upgrades to data-sharing and electronic submissions, support for responsible use of AI/machine learning (ML) and increased collaboration between the agency and industry.

The strategy for FY 2024 to 2027 acknowledges the growing importance of technology in drug and device development, as well as the challenges that accompany fast-paced scientific progress and innovation. IT-focused upgrades will be needed to keep up with ever-evolving technology and therapeutics, says Vid Desai, chief information officer for the agency’s Office of Digital Transformation.

“We are responding to rapid advancements and changes in demand from FDA’s regulated industries, competing for scarce IT talent, understanding use cases for emerging technologies (such as [AI]), enabling business process modernization, optimizing investment management, and continuing to break down barriers to data sharing and collaboration, all while protecting the assets, intellectual property, and personal information the public entrusts us with,” he said.

Read the FDA strategy report here.

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