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Report on FY 2003 and 2004 PDUFA Goals - continued

Manufacturing Supplements

Goal - Review and act on complete manufacturing supplements to NDAs and BLAs

The table below summarizes the review time goals for manufacturing supplements to NDAs and BLAs. The PDUFA goal for manufacturing supplements that require FDA's approval before the changes can be enacted is 90 percent of supplements within 4 months of submission. The PDUFA goal for manufacturing supplements that do not require FDA's approval before the changes can be enacted is 90 percent of supplements within 6 months of submission.

Workload

The total number of manufacturing supplements filed has been relatively steady over the past 3 years (FY 2002 through FY 2004). However, during the same period, the number of NDA manufacturing supplements filed has decreased while the number of BLA manufacturing supplements has increased.

Manufacturing Supplements Filed (Prior Approval / No Prior Approval) Table

Manufacturing Supplements

Performance

FY 2003 Submissions

FDA reviewed and acted on 98 percent (902 of 921) of manufacturing supplements, which required prior approval, within 4 months. FDA reviewed and acted on 99 percent (1,659 of 1,677) of manufacturing supplements, where no prior approval was required, within 6 months. Review performance on all manufacturing supplement reviews exceeded the 90 percent on-time PDUFA review goals.

FY 2003 Submissions Table

FY 2004 Submissions

As of September 30, 2004, more than 73 percent (612 of 843) of manufacturing supplements that require prior approval had been reviewed and acted on; and 97 percent were reviewed within the 4-month PDUFA goal. Sixty-three percent (1,035 of 1,638) of those that do not require prior approval had been reviewed and acted on, and 99 percent were reviewed within the 6-month PDUFA goal. With submissions still pending and not overdue, it is too early to make a final performance determination for FY 2004.

FY 2004 Submissions Table

First Cycle Filing Review Notification

Goal - Report substantive deficiencies (or lack of same) within 14 days after the 60-day filing date for original BLAs, NDAs, and Efficacy Supplements

This is the second year for this goal. FDA is to report substantive deficiencies (or lack of same) identified during the initial filing review to the sponsor by letter, telephone conference, facsimile, secure e-mail, or other expedient means within 14 days after the 60-day filing date. Performance levels progress from 50 percent on time for FY 2003 submissions to 90 percent for FY 2005 to FY 2007 submissions.

Workload

The total number of first cycle filings increased by 20 percent from FY 2003 to FY 2004.

First Cycle Filings Table

First Cycle Filing Review Notification

Performance

FY 2003 Submissions

FDA completed initial filing reviews for 84 percent (87 of 104) of original NDAs and all 8 of original BLAs within 14 days after the 60-day filing date. FDA completed initial filing reviews for 87 percent (105 of 121) of efficacy supplements within 14 days after the 60-day filing date. Performance on all first cycle filing review notifications exceeded the 50 percent on-time PDUFA review goals.

FY 2003 Submissions Table

FY 2004 Submissions

As of September 30, 2004, 85 percent (109 of 128) of NDAs, 78 percent (7 of 9) of BLAs and 81 percent (105 of 130) of efficacy supplements have received an initial filing review. Although it is too early to make a final determination, performance is well over the targeted performance levels for FY 2004.

FY 2004 Submissions Table

Reviewable Unit Letter Notification

Goal -- Issue discipline review letters for pre-submitted "Reviewable Units" of NDAs/BLAs

This is the first year for this goal. Under the Continuous Marketing Applications: Pilot 1 -- Reviewable Units for Fast Track Products Under PDUFA, applicants may submit a portion of their marketing application, reviewable unit (RU), before submitting the complete application for Fast Track Original NDAs and BLAs, based on meeting specific criteria for inclusion in the Pilot. An NDA/BLA may have more than one RU. Each RU is tracked independently. Under this goal, FDA is to issue discipline review letters for pre-submitted RUs to NDAs/BLAs within 6 months of receipt of submission. Performance levels progress from 30 percent on time for FY 2004 submissions to 90 percent for FY 2007 submissions.

Workload

The total number of reviewable units submitted in FY 2004 was 14.

Reviewable Unit Submissions Table

Reviewable Unit Letter Notification

Performance

FY 2004 Submissions

As of September 30, 2004, 38 percent (5 of 13) of NDA RUs had been reviewed and acted on and all within the 6-month review goal. With the remaining eight RUs still pending and not overdue as of September 30, 2004, it is too early to make a final determination. Preliminary performance is well over the targeted performance levels for FY 2004.

FY 2004 Submissions Table

Procedural and Processing Goals

This section reports on a number of PDUFA goals related to the IND phase of drug development and some aspects of the infrastructure of drug review. A detailed description of the goals, the annual performance targets, and definitions of terms can be found in Appendix A. This section reports on actions on items that occurred in FY 2004.

Meeting Management

• Meeting Requests: Notify requestor of formal meeting in writing within 14 days of request.
• Scheduling Meetings: Schedule meetings within goal date (within 30 days of receipt of request for Type A meetings, 60 days for Type B meetings, and 75 days for Type C meetings). If the requested date for any of these types of meetings is greater than 30, 60, or 75 days, as appropriate, from the date the request is received by the Agency, the meeting date should be within 14 days of the requested date.
• Meeting Minutes: Agency-prepared minutes, clearly outlining agreements, disagreements, issues for further discussion, and action items will be available to the sponsor within 30-calendar days of meeting.

Procedural and Processing Goals

Clinical Holds: Respond to sponsor's complete response to a clinical hold within 30 days of receipt.⁹

Major Dispute Resolution: Respond to sponsor's appeal of decision within 30 days of receipt.⁹

Special Protocol Question Assessment and Agreement: Respond to sponsor's request for evaluation of protocol design within 45 days of receipt.⁹

FY 2004 Performance Report | Previous | PDUFA III Management Initiatives

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