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The Last Days Of PDFs: Industry Works To Solve Its US 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. • Source: Screenshot

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 the necessary

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US FDA Adcomm To Consider If Genentech’s Columvi Study Generalizable To US

 
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EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

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