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US FDA IT Modernization Plan Will Lay Groundwork For Real-Time Data Submissions

Executive Summary

Principal deputy commissioner Amy Abernethy cites IND safety reporting and oncology review pilot program as areas that would benefit from enabling receipt of sponsor data in real time; plan describes near-term strategy for modernizing agency’s technical infrastructure, developing technology tools around regulatory ‘use cases’ and improving collaborations with data and tech companies.

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US FDA’s Abernethy Leaves Behind Legacy Of Tech Modernization, Real-World Data

After slightly more than two years as second-in-command, Abernethy says she’s leaving FDA because her initiatives were starting to develop their own momentum. Abernethy, who the agency’s acting chief information officer, worked to modernize FDA’s information technology infrastructure and data capabilities while also exploring confidently using real-world data to support regulatory decision-making.

US FDA’s Amy Abernethy Leaves Behind Legacy Of Tech Modernization, Real-World Data

After slightly more than two years as second-in-command, Abernethy tells the Pink Sheet she’s leaving FDA because the initiatives on which she was focused were starting to develop their own momentum. Abernethy, who also serves as the agency’s acting chief information officer, worked to modernize the FDA’s information technology infrastructure and data capabilities while also exploring ways to confidently use real-world data to support regulatory decision-making.

Taking The ‘O’ Out Of RTOR: US FDA’s Real-Time Review Primed For Expansion Beyond Oncology

Technology modernization efforts, the expansion of cloud-based submission capabilities, and the ongoing COVID-19 pandemic could serve as catalysts to broaden FDA’s Real-Time Oncology Review program beyond cancer therapeutics, Pfizer exec Richard Jahn says.

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