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FDA Launches Digital Modernization Plan To Complement Its Technology Modernization Plan

Executive Summary

Agency heads say the new plan will siphon and aggregate more data that could help the regulatory body make better and faster regulatory decisions.

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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.

FDA’s Second-In-Command, Amy Abernethy, Departing Agency

US FDA principal deputy commissioner Amy Abernethy is set to leave the agency by the end of April. The surprise news comes in the midst of the Biden administration still figuring out who they want to lead the FDA.

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