FDA rejects Northfield Labs PolyHeme BLA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA sends "refuse-to-file" letter to Northfield Labs in November regarding the firm's PolyHeme BLA submission. Northfield submitted a BLA for the polymerized blood substitute Aug. 28. According to the firm, the agency is "seeking additional information before accepting the application for filing." Northfield will be discussing the necessary steps with FDA "over the next few months"
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