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- Experts say MDUFA VI draft letter improves program while addressing FDA resource limitsIndustry experts note that the draft commitment letter for the upcoming Medical Device User Fee Amendments (MDUFA VI) offers enhancements over the current framework and takes into account the FDA’s…
- Baxter issues urgent correction for Volara breathing device circuits due to leak riskBaxter has sent an Urgent Medical Device Correction notice to customers using its Volara Positive Pressure Breathing System, advising that all patient circuits be corrected before further use. The…