Baxter News in Peritoneal Dialysis, Mayo Partnership

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Baxter International (Deerfield, IL) is developing a system to produce sterile solutions for peritoneal dialysis (PD) in patients’ homes. The company said it received FDA guidance about the regulatory pathway for the system, which would be integrated into Baxter’s Amia PD System with a small water-filtration device.

Baxter notes that the system for PD solutions plus the Amia PD system would be considered a combination product and was placed in the specific regulatory approval pathway the FDA uses when a product comprises a device plus a pharmaceutical product.

Baxter plans to begin a clinical trial in 2018, with regulatory submission