Baxter’s Clinolipid Could Offer Safety Advantages While Mitigating Shortage
This article was originally published in The Pink Sheet Daily
Though it doesn’t have a formal labeling claim, olive-oil based parenteral nutrition drug provides marketing advantages compared to soybean fat emulsions drugs, while helping to ease shortage.
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Agency will probably clear products based on non-inferiority studies with nutrition endpoints, but ultimately wants clinical outcomes trials.
As normal operations – and normal budget worries – resume, the agency has some meetings to reschedule.
Shutdown puts API shipments on a slow boat, but reviews of existing products can proceed with carry-over funds, even as new applications cannot be filed. CDC has largely halted its influenza program and NIH has ceased enrolling new patients in its clinical center.