NORWAY | New Guide on Institutions’ Responsibility for Research Ethics
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NETHERLANDS | New Investigational In Vitro Diagnostic Medical Device Dossier template Available
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EU | Revised EMA Guidance for Imposed PASS
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- USA | Draft FDA Guidance – Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products Gallery
USA | Draft FDA Guidance – Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products
USA | Draft FDA Guidance – Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products
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USA | Advancing Real-World Evidence Program Submission Deadline and New FAQsÂ
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MALAYSIA | New Decentralised Clinical Trial (DCT) Guidance
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- FRANCE | CNIL Publishes Results from its Digital Health Regulatory Sandbox Gallery
FRANCE | CNIL Publishes Results from its Digital Health Regulatory Sandbox
2023, August 2023, Data Privacy and Data Protection, Digital Health, EU, France, GDPR, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data
FRANCE | CNIL Publishes Results from its Digital Health Regulatory Sandbox
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GLOBAL | ICH Reflection Paper on Harmonised RWE Terminology
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UK | Implementation of the Future Medical Device Regulations
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