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 B.

Goals		On-Time Performance by Resubmission Year
		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 96	FY 97	FY 98	FY 99	FY 00
of Original NDAs	84	82	50 (19/31)	63 (17/46)	77 (26/51)
of Original BLAs	14	8	21 (5/16)	14 (2/12)	9 (1/8)
PDUFA Total	98	90	71 (24/47)	77 (19/58)	86 (27/59)

Performance:

FY 99 Submissions:

All 19 Class 1 resubmissions received in FY 99 were reviewed and acted upon within 2 months, and all 58 Class 2 resubmissions were reviewed and acted upon within 6 months. Review performance on both classes of FY 99 resubmissions exceeded the PDUFA review goals.

FY 99 Resubmissions		Reviewed and acted upon	Number on time	Percent on time
Class 1	4 months 2 months	19	19 19	100 100
Class 2	6 months	58	58	100

FY 00 Submissions:

As of September 30, 2000, 23 FY 00 Class 1 resubmissions had been reviewed and acted upon. All 23 met the 4-month review goal, and all but one met the 2-month goal. With only 4 Class 1 resubmissions still pending, review performance on FY 00 Class 1 resubmissions will exceed the review goals.

All but one of the Class 2 resubmissions that have been reviewed and acted upon have met the 6 month goal. While too many are still pending to make a final performance determination, current on-time performance stands at 97 percent.

FY 00 Resubmissions		Reviewed and acted upon	Number on time	Percent on time
Class 1	4 months 2 months	23	23 22	100 96
Class 2	6 months	30	29	97

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