required communications / biological product / biological product applications / similar products / manufacturing / chemical / related products / non-user fee products / manufacturing information / manufacturing process / chemical name / /
Organization
Division of Manufacturing and Product Quality / PDUFA V / FDA / office of Blood Research / office of Compliance and Biologics Quality / Public Health Service / Food and Drug Administration / CBER Office / Center for Biologics Evaluation and Research / Applications Division / Deputy Office / /
Position
Deputy Director of Applications Branch / Director / Division / General development discussion / Director / /