|Selected research from leading health care experts whose findings have a direct bearing on public policies effecting medical progress. Research is chosen based on its quality and relevance by the Medical Progress Today editorial staff.||
Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process
This study validates what many observers of the FDA had long assumed: that the Prescription Drug User Fee Acts (PDUFA,1992; renewed in 1997 and 2002), which mandated FDA performance goals in reviewing new drug applications in return for levying user fees from drug companies, significantly accelerated the downward trend in approval times for new drug applications (from 24.2 months in 1991 to 14.2 months in 2002) after it was enacted. The authors conclude that "of the total observed decline in approval times between 1991 and 2002, approximately two-thirds can be attributed to PDUFA." However, the study also noted that much of the decline occurred between 1992 and 1997, rather than during the ensuing 5 year period, 1997-2002.
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