PDUFA IV Management Initiatives Accomplishments
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|Expediting Drug Development||Draft guidance documents on clinical hepatotoxicity, non-inferiority trials, adaptive trail designs, and end of Phase 2(a) meetings||Guidances were being worked on and in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.