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of the preamble of this proposed rule, we discuss proposed policies for the Hospital Readmissions Reduction Program

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This criterion does not depend on the standard of safety and effectiveness on which FDA relies but on a demonstration of substantial clinical improvement in the Medicare population

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GO-MBT demonstrated enhanced antibacterial performance compared to unmodified GO, tested against Escherichia coli and Staphylococcus aureus

Phase 2 multi-institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma