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PDF's Last Days In US: Industry Works To Solve Its FDA Application Problem

 
• By Derrick Gingery

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.

Public Meeting: Modernizing FDA Data Strategy virtual meeting
FDA PRINCIPAL DEPUTY COMMISSIONER AMY ABERNETHY WAS AMONG THE PARTICIPANTS AT THE AGENCY'S 30 JUNE PUBLIC MEETING ON MODERNIZING ITS DATA STRATEGY.

A group of pharma companies is working to potentially streamline application submission and assessment by ending their reliance on so-called digital paper.

The project, known as Accumulus, involves creating a platform that would allow for rolling data flow, instead of the boluses of data at single time points now submitted, and include...

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