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US FDA's Abernethy 'Cautious' About Real-World Evidence

Executive Summary

FDA's principal deputy commissioner, who used to work in the real-world evidence field, said momentum is building, but more successful use cases are needed.

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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.

US FDA Tech Modernization Plan’s Costs Uncertain

Agency officials determining needs using existing budgets before requesting more funds and will engage with tech investors for design advice.

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