FDA,FY 2001 Performance Report for the Prescription Drug User Fee Act of 1992,Original New Product Applications

Report on PDUFA Goals: Original New Product Applications

Goal --Review and act upon complete original 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 2001, the goal was to review 90 percent in 12 months and 70 percent in 10 months. The statute allows three additional months for review of original NDA and BLA submissions that involve major amendments received within the last three months of their usual review intervals.

Goals		On-Time Performance by Submission Year
Goals		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 01 submissions assumes that all submissions received in the last two months of FY 01 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 97	FY 98	FY 99	FY 00	FY 01³
NDAs	117 (25/92)	109 (30/79)	121 (30/91)	121 (29/92)	92 (10/82)
BLAs	16 (3/13)	12 (8/4)	6 (1/5)	13 (4/9)	9 (3/6)
PDUFA Total	133 28/105	121 (38/83)	127 (31/96)	134 (33/101)	101 (13/88)
NMEs⁴		42 (19/23)	41 (16/25)	32 (17/15)	34 (8/26)

Performance

FY 2000 Submissions

For FY 2000 applications, FDA met the 6-month review goal for 32 of 33 priority submissions. One priority submission was late. FDA met the 12-month goal for standard submissions for 98 of the 101 standard submissions reviewed. Eighty-one percent of all standard applications and 65 percent of the NMEs and BLAs were reviewed and acted upon within 10 months, exceeding the 50 percent review goal in both cases.

FY 00 Submissions			Reviewed and acted upon	Number on time	Percent on time
Priority	6 month goal	All Applications	33	32	97
Priority	6 month goal	NMEs & BLAs	21	20	95
Standard	12 month goal	All Applications	101	98	97
	12 month goal	NMEs & BLAs	24	23	96
	10 month goal	All Applications	101	82	81
	10 month goal	NMEs & BLAs	24	15	62

FY 2001 Submissions

While it is too early to report meaningful review performance statistics for applications submitted in FY 2001, all priority applications that have been reviewed have met the 6 month review goal, and all standard applications that have been reviewed have met the 10 month review goal.

FY 01 Submissions			Reviewed and acted upon	Number on time	Percent on time
Priority	6 month goal	All Applications	8	8	100
Priority	6 month goal	NMEs & BLAs	7	7	100
Standard	12 month goal	All Applications	Too early to report meaningful review performance statistics. Ten standard applications have been reviewed and acted upon, all within 10 months.
	12 month goal	NMEs & BLAs
	10 month goal	All Applications
	10 month goal	NMEs & BLAs

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