Improving the Generic Drug Review Process and Review Queue Management <br>This key project has been retired as CDER has created new measures and key projects for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research. </b> A. Develop an Understanding of the Current StateCompletedCompletedMain1. Document the current state of review management within the Office9/15/2010Completed9/15/2010Main2. Draft a segmentation methodology for applications in the queue9/15/2010Completed9/15/2010Main3. Document the findings from internal FDA interviews9/15/2010Completed9/15/2010
B. Develop an Improvement AssessmentCompletedCompletedMain1. Document the overall improvement process10/15/2010Completed10/15/2010Main2. Determine impact of process improvements and queue management on the overall review queue10/15/2010Completed10/15/2010Main3. Draft a plan for internal communication10/15/2010Completed10/15/2010
C. Finalize RecommendationsCompletedCompletedMain1. Deliver final toolkit for process improvements and queue management1/1/2011Completed1/1/2011
D. Implementing the Recommendations from McKinseyON TRACKON TRACKMain1. Complete responseN/AN/AN/ASuba. Letter – drafted in clearance1/1/2012On TrackSubb. Public Communication – drafted in clearance1/1/2012On TrackSubc. Standard procedure for use of letter – in progress1/1/2012On TrackMain2. Dashboard for project managers to TRACK ANDA review processN/AN/AN/ASuba. Develop database tool – Done; review flow system6/13/2011Completed6/13/2011Subb. Roll-out across OGD – 100% complete10/1/2011 <i>6/1/2012</i>On TrackMain3. Implement more stringent filing criteriaN/AN/AN/ASuba. Develop revised criteria1/1/2011Completed6/1/2011Subb. Public communication – on website1/1/2012Completed6/1/2011Main4. Quality Management SystemN/AN/AN/ASuba. Develop list of needed IQPs10/18/2010Completed10/18/2010Subb. Train staff on IQPs – on goingSubc. Audits – OPS-wide audit12/31/2011Completed2/14/2012Main5. Separate DMF review from ChemistryN/AN/AN/ASuba. Establish DMF review teamCompleted4/1/2011Subb. Establish process for DMF review management - Drafted1/1/2012On TrackSubc. Audits – OPS-wide audit12/31/2011On TrackMain6. Count the number of complete response letters issued – initiate tracking 201210/1/2012Main7. Percentage of completed IQPs versus number of needed IQPs33% as of SeptemberMain8. Percentage of staff trained on IQPs – 95% of staff needing particular training are trained12/31/2011
word textword definitionhttp://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboard ਍††਍਍਍਍਍਍਍