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PHUSE/FDA CSS 2023 Summary
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Hot Topics
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Digital Health Technologies (DHTs)
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Integrated Analysis Data Reviewer’s Guide (iADRG) Package
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Integrated Analysis Data Reviewer’s Guide (iADRG) Package
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PHUSE/FDA CSS 2023 Summary
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Safety Analytics Webinar Series: Overall Safety Assessment – AE Groupings for Assessment of Safety Topics of Interest
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PHUSE Community Forum
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Scientific Evaluation of Safety Data and Aggregate Safety Assessment Planning for IND Safety Reporting
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Safety Analytics Webinar Series: Overall Safety Assessment – AE Groupings for Assessment of Safety Topics of Interest
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Overall Safety Assessment – Standard Safety Tables and Figures
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Safety Analytics Webinar Series: Interdisciplinary Safety Evaluation for Learning and Decision-Making
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Quality Tolerance Limits – Threshold Setting Methodologies
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