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USA | FDA Draft Guidance on Sex Differences Reinforces Expectations for Non-Interventional Studies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USA | FDA Draft Guidance on Sex Differences Reinforces Expectations for Non-Interventional Studies2026-01-09T14:18:59+00:00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

UK | HRA Describes Phased Approach to Implementing New Research Systems Platform (IRAS Replacement)

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UK | HRA Describes Phased Approach to Implementing New Research Systems Platform (IRAS Replacement)2025-12-07T15:38:34+00:00

SPAIN | Royal Decree 942/2025 on In-Vitro Diagnostic Medical Devices – Implications for PMPF Studies

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SPAIN | Royal Decree 942/2025 on In-Vitro Diagnostic Medical Devices – Implications for PMPF Studies2025-12-07T15:43:32+00:00
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