GLOBAL | ICH E6(R3) Annex 2 Reaches Step 4 — Final GCP Guidance Adopted for Trials Using Decentralised Elements, Pragmatic Approaches and Real-World Data GalleryGLOBAL | ICH E6(R3) Annex 2 Reaches Step 4 — Final GCP Guidance Adopted for Trials Using Decentralised Elements, Pragmatic Approaches and Real-World Data
GLOBAL | ICH E6(R3) Annex 2 Reaches Step 4 — Final GCP Guidance Adopted for Trials Using Decentralised Elements, Pragmatic Approaches and Real-World Data
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EU | First Public JCA Outputs Show How the HTA Regulation Is Changing Evidence Expectations for Oncology Medicines
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EU | EMA Publishes 2025 AI Observatory Report — AI Moves From Regulatory Concept to Practical Implementation Across the Medicines Lifecycle
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USA | FDA Seeks Input on Drug Repurposing to Address Unmet Medical Needs
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UK | HRA Publishes Two-Year Plan to Support Safe AI-Powered Innovation in Health and Social Care Research
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UK | NICE Reports Major Shift Away From SABA-Only Asthma Treatment — More Than One Million People Now Using AIR or MART Combination Inhalers
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EU | MDR/IVDR Simplification Proposal Moves into Active Scrutiny — Lifecycle Evidence Trade-Offs Under Debate
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EU | TEHDAS2 Launches New Public Consultations to Support Implementation of the European Health Data Space
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USA | FDA Highlights Expanding Role of Real-World Evidence in Medical Device Decision-Making GalleryUSA | FDA Highlights Expanding Role of Real-World Evidence in Medical Device Decision-Making
2026, March 2026, Medical Devices, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data
USA | FDA Highlights Expanding Role of Real-World Evidence in Medical Device Decision-Making
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