Report on PDUFA Goals

This report updates the Agency's review performance on the FY 99 application submissions and evaluates its performance in reviewing FY 00 application submissions and meeting other PDUFA II goals. All but two of the FY 99 submissions have been reviewed and acted upon, and final performance relative to the goals can now be reported. Only a preliminary performance assessment on FY 00 submissions is possible at this time. For submission categories with a 10- or 12-month review goal, it is too early to measure review performance. For those submission categories with a review goal that is shorter than 10 months, performance on submissions received early in the fiscal year provides an early-indicator of final review performance. Unless otherwise noted, all performance data in this section are as of September 30, 2000.

FDA's Center for Biologics Evaluation and Research (CBER) is in the process of changing from counting Product License Applications (PLAs) and Establishment License Applications (ELAs) separately to combining them as Biologic License Applications (BLAs). This report shows CBER's workload and performance on PLAs and BLAs only (i.e., Product Applications). To simplify notation, it uses BLA as a generic term for both BLAs and PLAs. Original and resubmitted ELAs have been dropped, both from workload counts and performance measurements. These new counts are reflected in the workload and performance data for the PDUFA I years, so trends into PDUFA II are consistent.

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