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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The opinions and analysis expressed in this Brief reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this document is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This document is not intended to endorse any company or product and should not be attributed as such.

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