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GLOBAL | ICH Concept Paper Endorsed for RWE Guideline on Medicines Effectiveness (ICH E23)

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GLOBAL | ICH Concept Paper Endorsed for RWE Guideline on Medicines Effectiveness (ICH E23)2026-01-09T14:48:31+00:00

EU | European Commission Proposes Health Innovation Package to Strengthen Biotech, Medical Devices and Cardiovascular Health

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EU | European Commission Proposes Health Innovation Package to Strengthen Biotech, Medical Devices and Cardiovascular Health2026-01-09T14:39:58+00:00

EU | EMA and HMA Highlight Role of Alzheimer’s Disease Patient Registries in Addressing Evidence Gap

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EU | EMA and HMA Highlight Role of Alzheimer’s Disease Patient Registries in Addressing Evidence Gap2026-01-09T14:35:29+00:00

EU | EMA Proposes Revision of Good Pharmacogenomic Practice Guideline to Reflect Scientific Advances

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EU | EMA Proposes Revision of Good Pharmacogenomic Practice Guideline to Reflect Scientific Advances2026-01-09T14:29:56+00:00

EU | Editorial Highlights Growing Importance of Real-World Data in Pharmacovigilance and Regulatory Science

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EU | Editorial Highlights Growing Importance of Real-World Data in Pharmacovigilance and Regulatory Science2026-01-09T14:24:01+00:00

USA | FDA Draft Guidance on Sex Differences Reinforces Expectations for Non-Interventional Studies

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USA | FDA Draft Guidance on Sex Differences Reinforces Expectations for Non-Interventional Studies2026-01-09T14:18:59+00:00

USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics

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USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics2026-01-09T14:13:46+00:00

USA | FDA Issues Updated Final Guidance on Use of Real-World Evidence for Medical Devices

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USA | FDA Issues Updated Final Guidance on Use of Real-World Evidence for Medical Devices2026-01-09T12:42:07+00:00

ITALY | AIFA Adds New RSO Functionalities to Align with 2024 Observational Study Guidelines

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ITALY | AIFA Adds New RSO Functionalities to Align with 2024 Observational Study Guidelines2026-01-09T12:36:06+00:00
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