MainTo efficiently and effectively review the results of clinical trials submitted for NDAs, BLAs and Efficacy Supplements, statistical reviewers in CDER need electronic datasets from the studies conducted by industry. Beginning in 2004, under the auspices of The Critical Path Initiative, the Agency recommended that sponsors voluntarily use standards developed by the Clinical Data Interchange Standards Consortium (CDISC) to describe and format these studies. Using datasets based on the Study Data Tabulation Model (SDTM) and derived variables described by Analysis Data Model (ADaM) standards, CDER reviewers can use powerful tools, techniques and software to perform their evaluations. These standards can improve the efficiency and quality of CDER’s review processes and thereby meet the expectations of CDER’s 21st Century Review Initiative. These metrics measure the progress of our efforts to encourage industry to submit standards-based electronic datasets needed for the timely, high quality review of clinical trials. <br>These measures have 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> Numbercolumn00Measure was implemented starting April 2010

Apr 20109May 201020Jun 201011Jul 20107Aug 201010Sep 201060

FY 2011 Total: 115

Oct 201010Nov 20108Dec 20108Jan 20118Feb 201110Mar 201113Apr 20115May 201113Jun 20116Jul 201111Aug 201112Sep 201111

FY 2012 YTD: 35

Oct 201111Nov 201112Dec 201112Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER DashboardSubNumber of Incoming New Drug Applications (NDAs), Biologics License Applications (BLAs), and Efficacy Supplements with electronic datasets receivedPercent0100Measure was implemented starting April 2010

Apr 201033May 201045Jun 201036Jul 201086Aug 201050Sep 2010330100

Oct 201050Nov 201025Dec 201050Jan 201150Feb 201140Mar 201138Apr 201140May 201138Jun 201133Jul 201127Aug 201133Sep 201173

Oct 201155Nov 201133Dec 201117Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012SubNumber of Incoming New Drug Applications (NDAs), Biologics License Applications (BLAs), and Efficacy Supplements with electronic datasets receivedPercent0100Measure was implemented starting April 2010

Apr 2010100May 201095Jun 201082Jul 2010100Aug 2010100Sep 2010830100

Oct 201070Nov 201088Dec 201088Jan 201188Feb 201170Mar 2011100Apr 2011100May 2011100Jun 201183Jul 201191Aug 201175Sep 201182100

Oct 201182Nov 2011100Dec 201175Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012SubNumber of Incoming New Drug Applications (NDAs), Biologics License Applications (BLAs), and Efficacy Supplements with electronic datasets receivedPercent0100Measure was implemented starting April 2010

Apr 201022May 201030Jun 20100Jul 201014Aug 201030Sep 2010170100

Oct 201020Nov 201025Dec 201038Jan 201113Feb 20110Mar 201154Apr 201120May 201131Jun 201167Jul 201155Aug 20110Sep 201164

Oct 201145Nov 201150Dec 201125Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012਍††਍਍਍਍਍਍਍