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Axendia Industry Brief: FDA’s Digital Transformation Journey

A Roadmap to the Agency’s Modernization Action Plans

“We’re not talking about PDFs and digital paper”, affirmed Dr. Abernethy. “We’re talking about digital transformation, use of cloud technologies, use of shared inter-operable data, digitized information.”

-Amy Abernethy, M.D., Ph.D., former Principal Deputy Commissioner & Acting Chief Information Officer

As Life-Science manufacturers embrace new technologies to speed time to market and products become more complex, the FDA is developing systems to be more efficient and effective in the 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 Industry Insight Brief was authored by Axendia and is presented by Certara. For more information on Axendia, visit

Undergoing digital transformation at your organization?