USA | FDA Reissues Draft Guidance on Substantial Evidence of Effectiveness — Non-Interventional Studies Expressly Recognised Within the Adequate and Well-Controlled Investigation Framework GalleryUSA | FDA Reissues Draft Guidance on Substantial Evidence of Effectiveness — Non-Interventional Studies Expressly Recognised Within the Adequate and Well-Controlled Investigation Framework
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EU | EDPB Publishes Draft Anonymisation Guidelines — New Framework Complements Scientific-Research Guidance And Raises Expectations For RWD Sharing GalleryEU | EDPB Publishes Draft Anonymisation Guidelines — New Framework Complements Scientific-Research Guidance And Raises Expectations For RWD Sharing
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EU | EMA Publishes Fourth RWE Framework Report — Darwin EU Expands Capacity as Regulator-Led RWD Studies Become More Embedded in EU Decision-Making GalleryEU | EMA Publishes Fourth RWE Framework Report — Darwin EU Expands Capacity as Regulator-Led RWD Studies Become More Embedded in EU Decision-Making
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UK | MHRA and NICE Continue Real-World Evidence Scientific Dialogue Programme — Expanding Early RWE Discussion to Medical Devices GalleryUK | MHRA and NICE Continue Real-World Evidence Scientific Dialogue Programme — Expanding Early RWE Discussion to Medical Devices
2026, June 2026, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, UK-
NORWAY | Government Consults on New European Health Data Space Act — National Implementation of EHDS Would Restructure Access to Health Data for Care, Research and Innovation GalleryNORWAY | Government Consults on New European Health Data Space Act — National Implementation of EHDS Would Restructure Access to Health Data for Care, Research and Innovation
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GREECE | National Biomedical Research Registry Delivered to IDIKA — New Digital Infrastructure Expected to Strengthen Oversight of Clinical and Biomedical Research GalleryGREECE | National Biomedical Research Registry Delivered to IDIKA — New Digital Infrastructure Expected to Strengthen Oversight of Clinical and Biomedical Research
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