CROATIA | Updated CEC Submission Requirements
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UK | MHRA Guidance on the Use of Real-World Data in Clinical Studies to Support Regulatory Decisions
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USA | Draft FDA Guidance on Registries
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LITHUANIA | Updated LBEK Submission Requirements for Medical Devices
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GERMANY | Major Refresh of the AKEK Biobanks Webpage
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USA – New FDA Draft Guidance for Industry: Data Standards for Drug and Biological Product Submissions Containing Real-World Data
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USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Development
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Norway – Consultation: Research Ethics Guide for Research on Human Remains
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EU – EMA Guideline on Registry-Based Studies
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