Report on PDUFA Goals: Original New Product Applications

Goal: Review and act upon complete NDAs and BLAs

The table below summarizes the annually decreasing review-time goals for original New Drug Applications (NDAs) and BLAs under PDUFA II. Over the five-year period, the goal of reviewing 90 percent of priority applications in six months remains constant. For standard applications, the review-time goals drop over the five-year period. For applications filed in FY 98, the goal was to review 90 percent in 12 months; for FY 02 applications, the goal is to review 90 percent in 10 months. For standard applications filed in FY 2000, the goal was to review 90 percent in 12 months and 50 percent in 10 months.

Goals		On-Time Performance by Submission Year
		FY 98	FY 99	FY 00	FY 01	FY 02
Priority	6 months	90% on time	90%	90%	90%	90%
Standard	12 months 10 months	90%	90% 30%	90% 50%	90% 70%	90%

Workload

The following table shows the number of original NDAs and BLAs filed in each of the last five years. The count of FY 00 submissions assumes that all submissions received in the last two months of FY 00 are filed. When FDA files a submission, it is deemed "complete" by PDUFA definition. FDA makes a filing decision within 60 days of an original application's receipt. All calculations of PDUFA review times are made, however, from the original receipt date of the filed application.

Original submissions filed (Priority/Standard):
	FY 96	FY 97	FY 98	FY 99	FY 004
NDAs	106	117 (25/92)	109 (30/79)	121 (30/91)	121 (27/94)
BLAs	9	16 (3/13)	12 (8/4)	6 (1/5)	13 (4/9)
PDUFA Total	115	133 (28/105)	121 (38/83)	127 (31/96)	134 (31/103)
NMEs5			42 (19/23)	41 (16/25)	35 (17/18)

Performance:

FY 99 Submissions:
For FY 99 applications, FDA met the 6-month review goal for priority submissions and the 12-month goal⁶ for standard submissions in every case. Two standard applications submitted late in FY 99 are still pending but have not exceeded the 12-month goal . Sixty-eight percent of all standard applications and 60 percent of the NMEs and BLAs were reviewed and acted upon within 10 months, exceeding the 30 percent review goal in both cases.

FY 99 Submissions			Reviewed and acted upon	Number on time	Percent on time
Priority	6 month goal	All Applications	31	31	100
		NMEs & BLAs	17	17	100
Standard	12 month goal	All Applications	94*	94	100*
		NMEs & BLAs	30	30	100
	10 month goal	All Applications	94	64	68
		NMEs & BLAs	30	18	60

*Two standard submissions still pending but not late.

FY 00 Submissions:

While it is too early to report meaningful review performance statistics for standard applications submitted in FY 00, all priority applications that have been reviewed have met the 6 month review goal.

FY 00 Submissions			Reviewed and acted upon	Number on time	Percent on time
Priority	6 month goal	All Applications	18	18	100
		NMEs & BLAs	9	9	100
Standard	12 month goal	All Applications	Too early to report meaningful review performance statistics. Sixteen standard applications have been reviewed and acted upon, all within 10 months.
		NMEs & BLAs
	10 month goal	All Applications
		NMEs & BLAs

 

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