The Last Days Of PDFs: Industry Works To Solve Its US FDA Application Problem
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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CBER Will Devote More Time To Non-COVID-19 Work Beginning In Six Months
Center for Biologics and Evaluation and Research is to resume normal operations at the beginning of 2023 and will stop prioritizing resources for COVID-19 regulatory work over non-COVID-19 matters.
Califf: More Learning Necessary During Generic Drug Lifecycle
The US FDA commissioner called for enhancements to postmarketing data collection and analysis for generic drugs.
BsUFA III Talks Could Move Cloud-Platform Goals Forward
US FDA wants to use biosimilars for a demonstration of cloud-based technology, an idea mentioned to increase the use of real-time review and enhance data analysis.