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The table below summarizes, by fiscal year, the performance measures set forth in the letters referenced in the FDAMA of 1997 (PDUFA II) and in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PDUFA III). Goal summaries for the earlier years of PDUFA II can be found in the Appendix of earlier PDUFA Performance Reports. The complete text of the commitment letters is on the Internet at: http://www.fda.gov/oc/pdufa/default.htm.
On-time Performance Level for Fiscal Year of Filing or Receipt
|
2003 | 2004 | 2005 | 2006 | 2007 |
|---|---|---|---|---|---|
| Review and act on priority original NDAs and BLAs within 6 months of receipt. 1 | 90% on time | 90% on time | 90% on time | 90% on time | 90% on time |
| Review and act on standard original NDAs and BLAs within 10 months of receipt. 1 | 90% on time | 90% on time | 90% on time | 90% on time | 90% on time |
| Review and act on priority efficacy supplements within 6 months of receipt. 1 | 90% on time | 90% on time | 90% on time | 90% on time | 90% on time |
| Review and act on standard efficacy supplements within 10 months of receipt. 1 | 90% on time | 90% on time | 90% on time | 90% on time | 90% on time |
| Review and act on all manufacturing supplements within 6 months of receipt and those requiring prior approval within 4 months of receipt. 2 | 90% on time | 90% on time | 90% on time | 90% on time | 90% on time |
| Review and act on Class 1 resubmitted original applications within 2 months of receipt. | 90% on time | 90% on time | 90% on time | 90% on time | 90% on time |
| Review and act on Class 2 resubmitted original applications within 6 months of receipt. 1 | 90% on time | 90% on time | 90% on time | 90% on time | 90% on time |
| Review and act on Class 1 resubmitted efficacy supplements within 2 months of receipt |
30% | 50% | 70% | 80% | 90% |
| Review and act on Class 1 resubmitted efficacy supplements within 4 months of receipt |
-- | 90% | 90% | 90% | -- |
| Review and act on Class 1 resubmitted efficacy supplements within 6 months of receipt |
90% | -- | -- | -- | -- |
| Review and act on Class 2 resubmitted efficacy supplements within 6 months of receipt. 1 | 90% | 90% | 90% | 90% | 90% |
The performance goals for priority and standard original NMEs will be the same as for all of the original NDAs but will be reported separately.
For biological products, for purposes of this performance goal, all original BLAs will be considered to be NMEs.
| Performance Area | FDA Activity | Performance Goal | Performance Level FY 2003 – FY 2007 |
|---|---|---|---|
| Meeting Management |
Meeting Requests -- Notify requestor of formal meeting in writing (date, time, place, and participants). | Within 14 days of receipt of request. | 90% on time |
| Meeting Management |
Scheduling Meetings -- Schedule meetings within goal date or within 14 days of requested date if longer than goal date. | Type A Meetings within 30 days of receipt of request. Type B Meetings within 60 days of receipt of request. Type C Meetings within 75 days of receipt of request. |
90% on time |
| Meeting Management |
Meeting Minutes -- FDA prepared minutes, clearly outlining agreements, disagreements, issues for further discussion and action times will be available to sponsor. | Within 30 days of meeting. | 90% on time |
| Clinical Holds | Meeting Minutes -- FDA prepared minutes, clearly outlining agreements, disagreements, issues for further discussion and action times will be available to sponsor. | Within 30 days of receipt of sponsor's response. | 90% on time |
| Special Protocol Question Assessment and Agreement |
Response to sponsor's request for evaluation of protocol design. | Within 45 days of receipt of protocol and questions. | 90% on time |
| Major Dispute Resolution | Response to sponsor's appeal of decision. | Within 30 days of receipt of sponsor's appeal. | 90% on time |
Performance Level and/or Implementation Timeline By Fiscal Year
Key: -- : Not Applicable; X : Action Due
| Performance Area | Initiative | Commitment | 2003 | 2004 | 2005 | 2006 | 2007 |
|---|---|---|---|---|---|---|---|
| Continuous Marketing Application |
To test whether providing early review of selected applications and additional feedback and advice to sponsors during drug development for selected products can further shorten drug development and review times. | Discipline review team of a "reviewable unit" for a Fast Track drug or biologic will be completed and a DRL issued within 6 months of the date of the submission. | --- | 30% | 50% | 70% | 90% |
| Independent Consultants for Biotechnology Clinical Trial Protocols | During the development period for a biotechnology product, a sponsor may request that FDA engage an independent expert consultant, selected by FDA, to participate in FDA's review of the protocol for the clinical studies that are expected to serve as the primary basis for a claim. | If FDA denies request, it will provide a written rationale within 14 days of receipt. | 100% | 100% | 100% | 100% | 100% |
| First Cycle Review Performance Proposal | For original NDA/BLA applications and efficacy supplements, FDA will report substantive deficiencies (or lack of same) identified in the initial filing review to the sponsor by letter, telephone conference, facsimile, secure e-mail, or other expedient means. | FDA will provide the sponsor a notification of deficiencies (or lack of same) within 14 days after the 60-day filing date. | 50% | 70% | 90% | 90% | 90% |
| Improving FDA Performance Management | Two specific initiatives will begin early in PDUFA III, supported from performance management initiative funds: 1) evaluation of first cycle review performance, and 2) process review and analysis within the two centers. | In FY 2003, FDA will contract with an outside consultant to conduct a comprehensive process review and analysis within CDER and CBER. | X | --- | --- | --- | --- |
| Risk Management | Pre-NDA/BLA Meeting with Industry: The intent of these discussions will be for FDA to get a better understanding of the safety issues associated with the particular drug/biologic and the proposed risk management plans, and to provide industry with feedback on these proposals so that they can be included in the NDA/BLA submission. | By the end of FY 2004, CDER and CBER will jointly develop final guidance documents that address good risk assessment, risk management, and pharma-covigilance practices. | --- | X | --- | --- | --- |
Implementation Deadline by Fiscal Year
Key: -- : Not Applicable; X : Action Due
| Initiatives | 2003 | 2004 | 2005 | 2006 | 2007 |
|---|---|---|---|---|---|
| The Agency will centralize the accountability and funding for all PDUFA Information Technology initiatives/activities for CBER, CDER, Office of Regulatory Affairs (ORA) and Office of the Commissioner (OC) under the leadership of the FDA CIO. The July 2001 HHS IT 5-year plan states that infrastructure consolidation across the department should be achieved, including standardization. The Agency CIO will be responsible for ensuring that all PDUFA III IT infrastructure and IT investments support the Agency's common IT goals, fit into a common computing environment, and follow good IT management practices. | X | X | X | X | X |
| The Agency CIO will chair quarterly briefings on PDUFA IT issues to periodically review and evaluate the progress of IT initiatives against project milestones, discuss alternatives when projects are not progressing, and review proposals for new initiatives. On an annual basis, an assessment will be conducted of progress against PDUFA III IT goals and, established program milestones, including appropriate changes to plans. A documented summary of the assessment will be drafted and forwarded to the Commissioner. A version of the study report redacted to remove confidential commercial or security information, or other information exempt from disclosure, will be made available to the public. The project milestones, assessment, and changes will be part of the annual PDUFA III report. | X | X | X | X | X |
| FDA will implement a common solution in CBER, CDER, ORA, and OC for the secure exchange of content, including secure e-mail, electronic signatures, and secure submission of, and access to, application components. | --- | --- | --- | --- | X |
| FDA will deliver a single point of entry for the receipt and processing of all electronic submissions in a highly secure environment. This will support CBER, CDER, OC, and ORA. The system should automate the current electronic submission processes such as checking the content of electronic submissions for completeness and electronically acknowledging submissions. | --- | --- | --- | --- | X |
| FDA will provide a specification format for the electronic submission of the e-CTD, and provide an electronic review system for this new format that will be used by CBER, CDER, and ORA reviewers. Implementation should include training to ensure successful deployment. This project will serve as the foundation for automation of other types of electronic submissions. The review software will be made available to the public. | --- | --- | --- | --- | X |
| Within the first 12 months, FDA will conduct an objective analysis and develop a plan for consolidation of PDUFA III IT infrastructure and desktop management services activities that will access and prioritize the consolidation possibilities among CBER, CDER, ORA, and OC to achieve technical efficiencies, target potential savings and realize cost efficiencies. Based upon the results of this analysis, to the extent appropriate, establish common IT infrastructure and architecture components according to specific milestones and dates. A documented summary of analysis will be forwarded to the Commissioner. A version of the study report, redacted to remove confidential commercial or security information, or other information exempt from disclosure, will be made available to the public. | --- | X | --- | --- | --- |
| FDA will implement CMM in CBER, CDER, ORA, and OC for PDUFA IT infrastructure and investments, and include other industry best practices to ensure that PDUFA III IT products and projects are of high quality and produced with optimal efficiency and cost effectiveness. This includes the development of project plans and schedules, goals, estimates of required resources, issues, and risks/mitigation plans for each PDUFA III IT initiative. | --- | --- | --- | --- | X |
| Where common business needs exist, CBER, CDER, ORA, and OC will use the same software applications, such as e-CTD software, and Commercial Off The Shelf solutions. |
--- | --- | --- | --- | X |
| Within 6 months of authorization, a PDUFA III IT 5-year plan will be developed. Progress will be measured against the milestones described in the plan. | X | --- | --- | --- | --- |
Definitions of Terms:
A. The term "review and act on" is understood to mean the issuance of a complete action letter after the complete review of a filed complete application. The action letter, if it is not an approval, will set forth in detail the specific deficiencies and, where appropriate, the actions necessary to place the application in condition for approval.
B. Under PDUFA I and II, receipt of a major amendment to original NDAs and BLAs in the last 3 months extended the goal date by 3 months. Under PDUFA III, this extension also applies to efficacy supplements and Class 2 resubmitted NDAs, BLAs, and efficacy supplements. Receipt of a major amendment to a manufacturing supplement in the last 2 months extends the goal date by 2 months (PDUFA III submissions only).
C. A resubmitted original application is a complete response to an action letter addressing all identified deficiencies.
D. Class 1 resubmitted applications are applications resubmitted after a complete response letter (or a not approvable or approvable letter) that include the following items only (or combinations of these items):
1. Final printed labeling
2. Draft labeling
3. Safety updates submitted in the same format, including tabulations, as the original safety submission with new data and changes highlighted (except when large amounts of new information, including important new adverse experiences not previously reported with the product, are presented in the resubmission)
4. Stability updates to support provisional or final dating periods
5. Commitments to perform Phase 4 studies, including proposals for such studies
6. Assay validation data
7. Final release testing on the last 1-2 lots used to support approval
8. A minor reanalysis of data previously submitted to the application (determined by the Agency as fitting the Class 1 category)
9. Other minor clarifying information (determined by the Agency as fitting the Class 1 category)
10. Other specific items may be added later as the Agency gains experience with the scheme and will be communicated via guidance documents to industry.
E. Class 2 resubmissions are resubmissions that include any other items, including any item that would require presentation to an advisory committee.
F. A Type A Meeting is a meeting that is necessary for an otherwise stalled drug development program to proceed (a "critical path" meeting).
G. A Type B Meeting is a 1) pre-IND, 2) end of Phase 1 (for Subpart E or Subpart H or similar products) or end of Phase 2/pre-Phase 3, or 3) a pre- NDA/BLA meeting. Each requestor should usually only request 1 each of these Type B meetings for each potential application (NDA and BLA) (or combination of closely related products, i.e., same active ingredient but different dosage forms being developed concurrently).
H. A Type C Meeting is any other type of meeting.
1. Receipt of a major amendment in the last 3 months extends the goal date by 3 months. Under PDUFA II this extension applied to original NDAs and BLAs only. Under PDUFA III, it also applies to efficacy supplements and Class 2 resubmitted NDAs, BLAs, and efficacy supplements.
2. Receipt of a major amendment in the last 2 months extends the goal date by 2 months (PDUFA III submissions only). This extension applies only to manufacturing supplements.