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

Report on PDUFA Goals: Resubmitted New Product Applications

Goal--Review and act upon resubmitted NDAs and BLAs.

A resubmission is a firm's response after an FDA action of "approvable," "not approvable," or "complete response" on an application. The applicable performance goal for a resubmission is determined by the year in which the resubmission itself is received, rather than its original application's year of submission. The definitions of Class 1 and Class 2 resubmissions can be found at the end of Appendix A.

Goals		On-Time Performance by Resubmission Year
Goals		FY 98	FY 99	FY 00	FY 01	FY 02
Class 1	6 months 4 months 2 months	90% on time 30%	90% 50%	90% 70%	90%	90%
Class 2	6 months	90%	90%	90%	90%	90%

Workload

Workload -- Resubmissions received *[Total (Class 1/Class 2)]*
	FY 97	FY 98	FY 99	FY 00	FY 01
of Original NDAs	82	50 (19/31)	63 (17/46)	80 (25/55)	61 (27/34)
of Original BLAs	8	21 (5/16)	14 (2/12)	9 (1/8)	15 (6/9)
PDUFA Total	90	71 (24/47)	77 (19/58)	89 (26/63)	76 (33/43)

Performance

FY 2000 Submissions:

All 26 Class 1 resubmissions received in FY 2000 were reviewed and acted upon within 4 months, 25 of them within 2 months. All but one of the 63 Class 2 resubmissions were reviewed and acted upon within 6 months. Review performance on both classes of FY 00 resubmissions exceeded the PDUFA review goals.

FY 00 Resubmissions		Reviewed and acted upon	Number on time	Percent on time
Class 1	4 months 2 months	26	26 25	100 96
Class 2	6 months	63	62	98

FY 2001 Submissions:

As of September 30, 2001, 24 FY 2001 Class 1 resubmissions had been reviewed and acted upon. Twenty-two of these met the 2-month goal. All of the Class 2 resubmissions that have been reviewed and acted upon have met the 6-month goal. With 9 Class 1 and 15 Class 2 resubmissions still pending and not overdue, it is too early to make a final performance determination, but current on-time performance for both classes of resubmissions exceeds the goals.

FY 01 Resubmissions		Reviewed and acted upon	Number on time	Percent on time
Class 1	2 months	24	22	92
Class 2	6 months	28	28	100

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