Prescription Drug User Fee Act (PDUFA); Public Meeting; Correction.  (30NOV01)                                     Click here for txt or pdf                                                                                                                   Prepublication display

Guidance for Industry: Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act;" Availability.    (21NOV01)
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The Guidance

Prescription Drug User Fee Act (PDUFA); Public Meeting.    (19NOV01)
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Prescription Drug User Fee Act (PDUFA) II Five-Year Plan--FY 2001 Update; Availability  (23MAY01)
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  FY 2001 Update

Agency Information Collection Activities; Announcement of OMB Approval; User Fee Cover Sheet  (28FEB01)
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Supporting Statement

Draft Guidance for Industry on Separate Marketing Applications and Definition of Clinical Data for Purposes of Assessing User Fees; Availability.  (22FEB01)
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The Draft Guidance