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The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.
Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. [2] 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. [3]
The Prescription Drug User Fee Act, or PDUFA, was arguably lawmakers' greatest gift to drugmakers and their investors. Before PDUFA was enacted in 1992, reviews of marketing applications were long ...
The Prescription Drug and User Fee Act, commonly referred to as PDUFA, was set to expire in September, but rather than wait to the last minute, amidst the debt ceiling and practically every other ...
It also reauthorizes the Prescription Drug User Fee Act. The PFUDA was first enacted in 1992 to allow the FDA to collect application fees from pharmaceutical companies when applying for approval for a drug. Since then, it has been reauthorized three times; first in 1997, then 2002, and most recently with the passage of the FDAAA in 2007.
For years, branded-drug makers have paid for speed at the Food and Drug Administration. In 1992, the Prescription Drug User Fee Act, or PDUFA, established a fee for submitting marketing ...
The act reauthorized, for five more years, the Prescription Drug User Fee Act of 1992 (PDUFA). This enabled the FDA to reduce the average time required for a drug review from 30 months to 15 months. FDA initiatives and programs
The U.S. is the global leader in delivering new medicines to patients thanks partly to the yet-to-be renewed Prescription Drug User Fee Act, Eddie Pauline writes.