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 did not change over the five years of PDUFA II. For manufacturing supplements that do require FDA's approval before the changes can be enacted, the goal times decreased from 6 months for FY 1998 submissions to 4 months for FY 2002 submissions.

Workload

Workload -- Manufacturing supplements filed (Prior Approval / No Prior Approval):

Performance

FY 2001 Submissions

Ninety-seven percent of the manufacturing supplements submitted in FY 2001 that did not require prior FDA approval were reviewed within 6 months. That level of performance exceeded the 90 percent on-time review goal.

Ninety-seven percent of the manufacturing supplements submitted in FY 2001 that required prior FDA approval also were reviewed within 6 months. Eighty-six percent of these were reviewed within 4 months. That level of performance exceeded FY 2001's goals of 90 percent and 70 percent respectively.

FY 2002 Submissions

As of September 30, 2002, almost 53 percent of the manufacturing supplements that do not require prior approval, and over 70 percent of those that do require prior approval had been reviewed. Ninety-eight percent those not requiring prior approval had been reviewed within the 6-month goal, and 95 percent of those that do require prior approval had been reviewed within the 4-month goal. Although it is too early to make a final determination with only 58 percent of the submissions reviewed, performance in both categories is well above the FY 2002 review goals.

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Web page created by cm 2003-MAR-15.