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- Euro Roundup: EMA posts draft guideline on approval dossiers for biomarker-guided therapiesThe European Medicines Agency (EMA) is seeking feedback on the information needed for the approval of biomarker-guided medicinal products.raps · 1d ago↗ source
- Experts: Specialized AI has great potential for regulatory, needs SME oversightBARCELONA – Experts said that specialized artificial intelligence (AI) tools can be invaluable in helping companies address regulatory needs for medical devices, while saving time and money, during…raps · 1d ago↗ source
- FDA seeks input on addressing patient-level data challenges for RWD/RWEThe US Food and Drug Administration (FDA) is requesting feedback on possible solutions that would help sponsors more effectively submit patient-level real-world data (RWD) and real-world evidence (…