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Updated: Jun 4, 2025

Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data
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开放之手倡议:通过合作和透明度,促进在监管提交中使用现实世界的证据

Elodie Baumfeld Andre1, Matthew Gee2, Carsten Magnus3

  • 1Roche Diagnostics, Santa Clara, California, USA.

Clinical pharmacology and therapeutics
|December 24, 2024
PubMed
概括

开放手倡议促进FDA和设备制造商之间的合作,以改善在体外诊断 (IVD) 监管审查中使用真实世界数据 (RWD) 和真实世界证据 (RWE). 这种方法增强了RWD/RWE收集市场前提交的信息.

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