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- FDA says MDUFA VI will prioritize review consistency and domestic focus over faster timelinesFDA officials explained that the next Medical Device User Fee Amendments, known as MDUFA VI, will aim to improve consistency in the review process. The agency said the new framework will emphasize…
- Medline recalls Hudson RCI neonatal heated wire breathing circuits over connector overheating riskMedline Industries announced a nationwide recall of its Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits. The recall was triggered after the company received reports of sporadic failures i…