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 (…raps · 1d ago↗ source
- Novartis' Zolgensma linked to tumors as FDA probes gene therapy and orders GLP-1 eye risk warningsNovartis confirmed that nine patients who received its Zolgensma gene therapy for spinal muscular atrophy have developed tumors, prompting the FDA to open an investigation into the approved treatme…