MainThe Cross-Discipline Team Leader (CDTL) is a new concept under 21st Century Review Process in CDER. CDTLs, generally appointed based on the nature of the submissions, e.g., serve as the medical team leader for applications containing clinical data. The CDTL provides day-to-day management of the review, performs a secondary review of the overall application taking into account all discipline reviews and recommendations, and maintains consistency of regulatory decisions and direction of the review. This measure reflects the number of submissions where clinical pharmacology may have a bigger impact than other disciplines. <br>This measure has been retired as CDER has created new measures 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> columnPerformance measure implemented April 2011

Apr 20111May 20110Jun 20110Jul 20111Aug 20111Sep 20111

FY 2012 YTD: 5

Oct 20112Nov 20113Dec 20110Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboardword textword definition