The European Commission has updated its questions and answers (Q&As) document on the incoming clinical trials regulation
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Recentes
- FDA Examples of Real-World Evidence Used in Medical Device Regulatory Decisions
- FDA eMDR – Electronic Medical Device Reporting
- ACT EU Draft Guidance on Clinical Trials During Public Health Emergencies
- EMA’s ePI Roadmap
- Sponsor Frequently Asked Questions Clinical Trial Information System (CTIS) Frequently Asked Questions (FAQs) on the Sponsor’s workspace
- The new CTIS Sponsor Handbook (v6.2, March 2026)
- New revision of the Q&A document on art. 10(a) interruption of supply published
- IMDRF Technical Framework for Artificial Intelligence Life Cycle Management” (IMDRF AIML WG N93 – April 2026)