Trends in NDA and BLA Submissions and Approval Times

FY 2008 PDUFA Performance Report Table of Contents

PDUFA-enabled improvements in application quality and review efficiency have had an impact on the overall time to marketing approval. FDA tracks a variety of metrics related to the process of human drug review. The time-to-approval statistics are affected by a number of factors including the following: total number of NDA and BLA submissions, overall quality of submitted applications, number of newly submitted priority applications, and number of review staff relative to the review workload. These factors can vary from year to year. The following charts provide an update on trends in submissions and overall approval times.

Total Number of NDAs and BLAs Filed in FY 2008 Reaches a 10-Year High. Overall numbers of NDAs and BLAs filed in FY 2008 reached a 10-year high with 143 filings (see graph below). The 10-year (FY 1999 to FY 2008) average number of filings was 121 per year with the number of NDAs versus BLAs varying somewhat from year to year. However, the total number of NDAs and BLAs has increased in five of the past 8 years, decreasing in FY 2005 and again in FY 2007. In FY 2008, 22 percent of the workload was priority applications, which represent significant therapeutic gains. This ratio is consistent with the 10-year average of priority versus standard applications, which over time represents just over one-fifth (22 percent) of the workload for reviewers.

Median Time to Approval For Priority Applications Remained at 6 Months for the Fifth Straight Year While Median Time to Approval for Standard Applications Rose.

Based on applications approved through September 30, 2008, and historical data indicating approximately 80 percent of all filed applications will eventually be approved, the estimated median approval time for priority applications for FY 2007 is 6.0 months (see graph below). This is the fifth straight year (FY 2003 to FY 2007) for these historically low levels and reflects FDA’s efforts to increase approvals of priority applications in the first review cycle (see next paragraph). The estimated median approval time for standard applications in FY 2007 was 15.1 months.

Percentage of First Cycle Approvals for Priority NDAs and BLAs Increased for the Sixth Straight Year. 

The percentage of priority NDAs and BLAs approved in the first review cycle has steadily increased from 15 percent in FY 2001 to 74 percent in FY 2007 (see graph to the right). The percentage of standard applications approved in the first review cycle decreased in FY 2007 to an estimated 31 percent. With reviews still in the first cycle as of September 30, 2008, this percentage could increase up to 37 percent.

Next page: PDUFA Workload: FY 2003 through FY 2008