The number of cross-discipline reviews led by OCP as cross-disciplinary team leaders (CDTLs)
Dictionary: The 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.
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.
Fiscal Year - 2012
FY 2012 YTD: 5
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.