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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]
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 ...
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]
Prescription Drug User Fee Act (PDUFA) of 1992, PL 102–571 (October 29, 1992) Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994, PL 103–396 (October 22, 1994) Dietary Supplement Health And Education Act of 1994, PL 103–417 (October 25, 1994) Food Quality Protection Act of 1996, PL 104–170 (August 3, 1996)
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.
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