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After discharge from the NICU for a post-neonatal encounter, use Z87.39 (personal history) unless the prematurity-related condition directly affects current management

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If scheduled, the meeting typically occurs 1 to 2 months before the approval decision date (called the PDUFA date)

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Commercially, manufacturers face pricing pressure from the competitive dynamics of the emerging generic market while simultaneously needing to recover substantial capital investments in dedicated manufacturing infrastructure