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- 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…raps · 16d ago↗ source
- STAT+: AIDS activists slam Biden R&D deal with Gilead over HIV prevention drug patentsA group of AIDS activists obtained an R&D pact at the heart of a settlement between the U.S. government and Gilead Sciences over patents for HIV prevention.