Japan’s EHR Databases Face Standardization Hurdles for Regulatory Use
A review of eight Japanese EHR databases highlights their broad data coverage but identifies critical gaps in standardization and patient ...
Tag: regulatory affairs
Thermal packs and heating pads dominate FDA device adverse-event reports, study finds
A retrospective analysis of 4,934 FDA device reports from 2016 to 2025 found that passive thermal packs and powered heating ...
PBMC-Based Framework Brings Standardized Validation to Flow Cytometry Assays in Cell Therapy Development
Researchers at Heidelberg University Hospital have developed a PBMC-based proof-of-principle framework for fit-for-purpose validation of flow cytometry assays in cellular ...
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Mothers who receive childcare support from maternal grandparents show more parental warmth, finds NTU Singapore study
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University of Seville Breaks 120-Year-Old Mystery, Revises a Key Einstein Concept
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Bee body mass, pathogens and local climate influence heat tolerance
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Researchers record first-ever images and data of a shark experiencing a boat strike
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Groundbreaking Clinical Trial Reveals Lubiprostone Enhances Kidney Function
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