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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.
Amazing. Absolutely amazing. 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 ...
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 ...
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]
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.
Under the Prescription Drug User Fee Act, the Food and Drug Administration has a limited timespan (known as the PDUFA date) to decide a New Drug Application, Abbreviated New Drug Application or Biologics License Application. The FDA may either approve the application or issue a Complete Response Letter. [2]
Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Fee Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – standard review and priority review.
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