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- Diamantas backtracks on Makary’s policies issued in journal articlesThe acting commissioner of the US Food and Drug Administration (FDA) has clarified that certain policies disseminated in medical journals by former FDA Commissioner Marty Makary are not official ag…raps · 15d ago↗ source
- Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing DevicesVolara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.fda medwatch · 16d ago↗ source
- Experts: Industry to benefit from focused follow-ups, major deficiency letters in MDUFA VIIndustry experts say the draft commitment letter for the next Medical Device User Fee Amendments (MDUFA VI) program negotiated by the US Food and Drug Administration (FDA) and the medtech industry…