In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application.
[1] 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.
Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months.
The PDUFA date may be extended by the Food and Drug Administration in certain circumstances.
[9] The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected.