Legal basis The Prescription Drug User Fee Act was first passed in 1992 , and  must be reauthorized every five years. 
History Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals. Under the PDUFA regime, The PDUFA must be reauthorized every five years. The current version, PDUFA VI, was reauthorized as part of the Food and Drug Administration Reauthorization Act (FDARA) signed on 18 August 2017. The reauthorization will expire in September 2022.
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Legal basis
History Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months.
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to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals. Under the PDUFA regime,
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The PDUFA
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The current version, PDUFA VI, was reauthorized as part of the Food and Drug Administration Reauthorization Act (FDARA) signed on 18 August 2017. The reauthorization will expire in September 2022.