EU | EMA 2023 – 2028 AI Workplan
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USA | FDA Finalises Digital Health Technologies (DHT) Guidance
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- USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products Gallery
USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products
December 2023, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA
USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products
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LEBANON | Significant Enhancements to IRB Operations
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USA | FDA Finalises Guidance on “Data Standards for Drug and Biological Product Submissions Containing Real-World Data
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UK | Updates to Commercial Model Agreements
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UK | Removal of the Commercial Standalone Data Processing Agreements
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- EU | EMA Catalogues of Data Sources and Non-Interventional Studies Go Live in February 2024 Gallery
EU | EMA Catalogues of Data Sources and Non-Interventional Studies Go Live in February 2024
December 2023, EU, Members-Only, RWD to Support Reg Decisions, Secondary Use of Existing Data, Significant Update
EU | EMA Catalogues of Data Sources and Non-Interventional Studies Go Live in February 2024
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EU | Data Quality Framework for EU Medicine Regulation Finalised
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