In United States pharmaceutical regulatory practice, the<unk>  is the colloquial name for the<unk>  by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application. It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and Drug Administration's drug approval activities in return for adhering to a largely fixed timetable of regulatory actions.
PDUFA date
DJO Global
Independent SAGE
QuikClot
QTY Code
DirectHit
EpiData
GPnotebook