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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UK | Proportionate Approval Route Introduced for Studies Involving NHS Staff as Research Participants
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UK | HRA Advances Digital Transformation of Non-CTIMP Approvals with User-Centred Design Approach
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EU | EMA Publishes New GVP Module on Pregnancy and Breastfeeding — Implications for Real-World Safety Research
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BRAZIL | Ministry of Health Advances Implementation of Law 14,874/2024 Through Platform Reform and Governance Measures
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USA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information GalleryUSA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information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USA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information
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