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Study supporting the monitoring of the availability of medical devices on the EU market Study overview and survey results of the 2nd EO survey with data status 31 October 2024
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- ICH E6(R3) update – New training materials available (Jan 2026)
- 2025 EMA’s key recommendations in human medicines.
- Guiding principles of good AI practice in medicine development
- European Pharmacopoeia publishes new data quality framework
- FDA GUIDANCE DOCUMENT: Clinical Decision Support Software! Guidance for Industry and Food and Drug Administration Staff
- Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products Guidance for Industry
- The Use of Generative Artificial Intelligence in Research
- FDA GUIDANCE ON General Wellness: Policy for Low Risk Devices