About FDA
PDUFA IV Management Initiatives Accomplishments
FY 2008 PDUFA Performance Report Table of Contents
The management initiatives FDA committed to achieve under PDUFA IV were designed to improve the overall application review process. Please see Appendix A for specific details about the initiatives.
| Performance Area | Management Initiatives | FY 2008 Accomplishments |
|---|---|---|
| Enhancement of Drug safety | Publish a PDUFA IV Drug Safety 5-Year Plan. | FDA published the draft PDUFA IV Drug Safety 5-Year Plan on FDA web site in April 2008. |
| Publish a request for proposals (RFP) for best ways to assess public health benefit of collecting adverse event reports throughout product life cycle. | FDA held a public workshop in January 2008. FDA issued a request for information (RFI) in April 2008. | |
| Hold a public workshop to identify epidemiology best practices. | FDA held a public workshop in May 2008 to gather information to develop a guidance document on epidemiology best practices. | |
| Expand access to database resources. | FDA developed a collaboration process with several federal agencies that enable access to large databases for drug safety effects and signals. | |
| Enhance adverse event reporting systems and surveillance tools. | Commercial product demonstrations were completed in August 2008 as part of FDA’s effort to modernize CDER’s adverse event reporting system to add signal detection and tracking tools. | |
| Proprietary Names | Final guidance document on contents of a complete submission package for a proposed proprietary drug/ biological product name | FDA drafted a guidance titled “Complete Submission for the Evaluation of Proprietary Names.” |
| Public technical meeting to discuss elements necessary to create a concept paper describing the pilot program | The draft concept paper was prepared for the public workshop which was held in June 2008. | |
| First Cycle Review Performance Proposal | Harmonized standard operating procedures for notification of planned review timelines | CDER Manual of Policies and Procedures posted in July 2008. CBER standard operating procedures and policies were under review as of September 30, 2008. |
| Training on standard operating procedures. | Staff training completed. | |
| Expediting Drug Development | Draft guidance documents on clinical hepatotoxicity, non-inferiority trials, adaptive trail designs, and end of Phase 2(a) meetings | Guidances were being worked on and in final phases of completion as of September 30, 2008. |
| Postmarketing Study Commitments – Standard Operating Procedures | Harmonized Standard Operating Procedures for Requesting Applicants to Agree in Writing to Voluntary Postmarketing Study Commitments | CBER and CDER standard operating policies and procedures manual and MAPP respectively were in clearance process as of September 30, 2008. |
| Improving FDA Performance Management |
Conduct 3 major program assessments: Conduct other studies and evaluations of the drug review process as needed to improve performance management. |
● FDA awarded a contract in 2008 to perform an independent evaluation of the PDUFA IV adjustment for changes in review activities used in the PDUFA workload adjuster. ● The procurements for GRMPs implementation and the electronic review impact were in the planning stages as of September 30, 2008. ● A contract was awarded in 2008 to implement CDER’s quality management plan for the chemistry and manufacturing controls (CMC) quality management system. |
Next page: PDUFA IV Electronic Applications and Submissions Accomplishments
