UK | NICE Launches National HealthTech Access Programme to Accelerate Adoption of Innovative Diagnostics and Digital Tools
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GLOBAL | New ICH M15 Guideline Establishes Global Framework for Model-Informed Drug Development
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EU | HTA Coordination Group Publishes 2025 Annual Report on First Year of EU HTA Regulation Implementation
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EU | ENCePP Publishes 2025 Annual Activity Report Highlighting New Working Groups and RWE Priorities
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AUSTRALIA | TGA Publishes Guidance on Regulation and Post-Market Responsibilities for Software-Based Medical Devices
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- USA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information Gallery
USA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information
2026, January 2026, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA
USA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information
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- USA | FDA Approves Paediatric Rare Disease Treatment Supported by Real-World Evidence Gallery
USA | FDA Approves Paediatric Rare Disease Treatment Supported by Real-World Evidence
2026, January 2026, Members-Only, Minor Update, Rare Diseases, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA
USA | FDA Approves Paediatric Rare Disease Treatment Supported by Real-World Evidence
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- UK | Health Data Research Service Seen as Catalyst for Real-World Research — Alignment with European Health Data Space Highlighted Gallery
UK | Health Data Research Service Seen as Catalyst for Real-World Research — Alignment with European Health Data Space Highlighted
2026, EHDS, January 2026, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, UK
UK | Health Data Research Service Seen as Catalyst for Real-World Research — Alignment with European Health Data Space Highlighted
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UK | NICE Draft Guidance Recommends Digital Asthma Management Tools with Conditional Use Pending Further Real-World Evidence
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