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Background - PDUFA Goals

Table of Contents: PDUFA III Five-Year Plan

Previous Section : Background - PDUFA III

The goals for PDUFA III are challenging, diverse, and resource intensive. Many of the goals require the development of guidance documents and databases to track performance. The development of infrastructure and tools necessary to enhance electronic application receipt and review is also required. The following table provides an overview and comparison of the major goals by the end of PDUFA I, PDUFA II, and PDUFA III. Some of the goals are phased in gradually over time, but only the goal for the final year, FY 2007, is reflected in this summary table. For more detail on the actual goals and FDA’s performance, see FDA’s latest Performance Report on the Internet. In addition to the summarized goals described below, over the five-year PDUFA III period, FDA is to also undertake a pilot project in a new type of application review process designated “continuous marketing application,” to study ways to complete more reviews in the first review cycle, and to undertake some initiatives aimed at improving review performance.

Summary Comparison of Goals at the End of PDUFA I, II, and III

Goal PDUFA I PDUFA II PDUFA III
Complete review of priority original new drug and biologic applications and efficacy supplements 90% in 6 months
Complete review of standard original new drug and biologic applications and efficacy supplements 90% in 12 months 90% in 10 months
Complete review of manufacturing supplements 90% in 6 months 90% in 4 months if prior approval needed, 6 months otherwise
Complete review of resubmitted new drug and biologic applications 90% in 6 months 90% of class 1 in 2 months and 90% of class 2 in 6 months
Complete review of resubmitted efficacy supplements No Goal 90% in 6 months 90% of class 1 in 2 months and 90% of class 2 in 6 months *
Discipline review letters for pre-submitted "Reviewable Units" of new drug and biologic applications No Goal 90% in 6 months *
Report of substantive deficiencies (or lack thereof) No Goal 90% within 14 days of filing date *
Respond to industry requests for meetings No Goal 90% within 14 days
Meet with industry within set times No Goal 90% within 30, 60, or 75 days, depending on type of meeting
Provide industry with meeting minutes No Goal 90% within 30 days
Communicate results of review of complete industry responses to FDA clinical holds No Goal 90% within 30 days
Resolve major disputes appealed by industry No Goal 90% within 30 days
Complete review of special protocols No Goal 90% within 45 days
Electronic application receipt and review No Goal In place by the end of FY 2002 Enhanced by the end of FY 2007

* Items noted with an asterisk are phased in gradually over time. Only the goal for the final year, FY 2007, is shown here.

 

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