faq data act

Recentes

• 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