FDA,Manufacturing Supplements

Report on PDUFA Goals: Manufacturing Supplements

Goal: Review and act upon complete manufacturing supplements to NDAs and BLAs

The review performance goals for manufacturing supplements that do not require FDA approval before the changes they specify can be enacted do not change over the five years of PDUFA ii. For manufacturing supplements that do require FDA's approval, the goal times decrease from 6 months for FY 98 submissions to 4 months for FY 02 submissions.

Goals		On-Time Performance by Submission Year
Goals		FY 98	FY 99	FY 00	FY 01	FY 02
Prior approval not required	6 months	90% on time	90%	90%	90%	90%
Prior approval required	6 months 4 months	90%	90% 30%	90% 50%	90% 70%	90%

Workload

Workload -- Manufacturing supplements filed (Total / Prior Approval Required):
	FY 96	FY 97	FY 98	FY 99	FY 00⁴
to NDAs	1,218	1,262	1,463	1,459 (900)	1,446 (708)
to BLAs	261	338	371	477 (259)	569 (244)
PDUFA total	1,479	1,600	1,834	1,936 (1,159)	2,015 (952)

Performance:

FY 99 Submissions:

Ninety-eight percent of the manufacturing supplements that did not require prior FDA approval submitted in FY 99 were reviewed within 6 months. That level of performance exceeded the 90 percent on-time review goal.

Ninety-eight percent of the manufacturing supplements that required prior FDA approval submitted in FY 99 also were reviewed within 6 months. Seventy-six percent of these were reviewed within 4 months. That level of performance exceeded FY 99's goals of 90 percent and 30 percent respectively.

FY 99 Submissions		Reviewed and acted upon	Number on time	Percent on time
Prior approval not required	6 months	777	759	98
Prior approval required	6 months 4 months	1159	1141 887	98 76

FY 00 Submissions:

As of September 30, 2000, almost 59 percent of the manufacturing supplements that do not require prior approval, and 64 percent of those that do require prior approval had been reviewed. Ninety-nine percent of both categories of manufacturing supplements had been reviewed within 6 months, and 82 percent of those requiring prior approval had been reviewed within 4 months. Although it is too early to make a final determination with only 61 percent of the submissions reviewed, performance in all categories is well above the FY 00 review goals.

FY 00 Submissions		Reviewed and acted upon	Number on time	Percent on time
Prior approval not required	6 months	625	620	99
Prior approval required	6 months 4 months	610	605 503	99 82

Next Page | Table of Contents | Previous Page

FDA Home Page | Search | A-Z index | Site Map | Contact FDA

FDA/Office of Planning
Web page created by cm 2001-MAR-01.