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USA – New FDA Draft Guidance for Industry: Data Standards for Drug and Biological Product Submissions Containing Real-World Data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USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Development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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UK | Revised Reporting Requirements for Non-CTIMPs
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AUSTRALIA | Updated Requirements for Post-Marketing Surveillance Studies
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- USA – New FDA Draft Guidance for Industry: “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products Gallery
USA – New FDA Draft Guidance for Industry: “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
USA – New FDA Draft Guidance for Industry: “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
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