MainQuality by Design (QbD): A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management (ICH Q8R2). The implementation of QbD will enhance the assurance of pharmaceutical quality in the U.S. market, improve the quality of Chemistry, manufacturing, and controls information submitted in Investigational New Drug (IND), New Drug Application (NDA), NDA supplement, and Drug Master File (DMF) submissions, and improve the ONDQA regulatory review processes. <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> PercentAnnual Target: 20%

Oct 2009-Nov 2009-Dec 2009100Jan 201050Feb 201033Mar 201050Apr 201050May 201050Jun 201050Jul 201040Aug 201033Sep 201027Annual Target: 20%

Oct 201050Nov 201050Dec 201038Jan 201127Feb 201133Mar 201129Apr 201124May 201117Jun 201120Jul 201120Aug 201120Sep 2011190

Oct 20110Nov 201120Dec 201123Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012SubPercentage of meetings with sponsors that include discussion of Quality by Design (QbD) information. Cumulative total reported for the Fiscal Year.(1) Includes cancelled meetings where preliminary responses were sentNumbercolumn020

Oct 20090Nov 20090Dec 20091Jan 20101Feb 20101Mar 20102Apr 20102May 20103Jun 20104Jul 20104Aug 20104Sep 20104040

Oct 20101Nov 20102Dec 20103Jan 20113Feb 20116Mar 20117Apr 20117May 20117Jun 20116Jul 20119Aug 20119Sep 20119

Oct 20110Nov 20111Dec 20113Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012SubPercentage of meetings with sponsors that include discussion of Quality by Design (QbD) information. Cumulative total reported for the Fiscal Year.(1) Includes cancelled meetings where preliminary responses were sent.Numbercolumn020

Oct 20090Nov 20090Dec 20091Jan 20102Feb 20103Mar 20104Apr 20104May 20106Jun 20108Jul 201010Aug 201012Sep 201015050

Oct 20102Nov 20104Dec 20108Jan 201111Feb 201118Mar 201124Apr 201129May 201142Jun 201145Jul 201145Aug 201146Sep 201148

Oct 20112Nov 20115Dec 201113Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboard