FDA’s Digital Transformation Journey

A Roadmap to the Agency’s Modernization Action Plans

As Life-Science manufacturers embrace new technologies to speed time to market and products become more complex, the FDA has created an Office of Digital Transformation (ODT) to support the effective review, approval, and regulation of human drugs, biological products, and medical devices.

To achieve its goals, FDA is doubling down on cloud technologies and the use of shared inter-operable data and structured information. This approach enables longitudinal evaluation and modern capabilities like artificial intelligence (AI) for prediction and blockchain for track & trace. It also expedites the adoption of computerized modeling and simulation to inform clinical trial design, predict clinical outcomes, demonstrated safety and effectiveness, identify relevant patient populations, and support regulatory submissions.

This Insight Brief provides a roadmap to FDA’s Digital Transformation Journey.

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