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The Last Days Of PDFs: Industry Works To Solve Its US FDA Application Problem

Executive Summary

The goal is a platform where sponsors could enter data that multiple regulators could view in real-time, rather than rely on ‘digital paper’ – pdfs and other static file formats that require health agencies to reenter the data in order to analyze it.

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Re-Wiring US FDA’s Regulatory Thinking

The efforts to upgrade FDA’s information technology infrastructure may be opening up into an opportunity to reinvent its processes for regulatory decision making.

Re-Wiring US FDA’s Regulatory Thinking

The efforts to upgrade FDA’s information technology infrastructure may be opening up into an opportunity to reinvent its processes for regulatory decision making.

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