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USA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information GalleryUSA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information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USA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information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 GalleryUSA | 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UK | NICE Draft Guidance Recommends Digital Asthma Management Tools with Conditional Use Pending Further Real-World Evidence
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GLOBAL | CIOMS Working Group Highlights Value of Pharmacoepidemiology for Public Health – Firmly Grounded in Real-World Research
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GLOBAL | Real-World Research Validates Stability of Novel Polio Vaccine – Delivering Impact in Outbreak Settings
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EU | EMA (and FDA) Publish Guiding Principles on Good AI Practice in Drug Development
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CANADA | New Canada’s Drug Agency Resource Explains National Drug Pathway, Highlighting Real-World Data Role
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