MainThe number of sNDA and sBLA reviews, for therapeutic protein and monoclonal antibody products, completed and signed off by OBP within the month. Includes all IQA reviews, primary reviews, summary and/or executive reviews. These reviews evaluate the impact of manufacturing changes on the quality of marketed products. These reviews cover quality related aspects of safety including immunogenicity. <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> Number0

Oct 20092Nov 20093Dec 20090Jan 20102Feb 20102Mar 20101Apr 20100May 20101Jun 20101Jul 20102Aug 20103Sep 201000

FY 2011 Total: 30

Oct 20101Nov 20103Dec 20103Jan 20112Feb 20115Mar 20110Apr 20113May 20113Jun 20111Jul 20113Aug 20113Sep 201130

FY 2012 YTD: 4

Oct 20111Nov 20110Dec 20113Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Office DashboardMainNumber0

Oct 200914Nov 200911Dec 20099Jan 20107Feb 20109Mar 201010Apr 201017May 201010Jun 201019Jul 20109Aug 201010Sep 2010120

FY 2011 Total: 358

Oct 20104Nov 201013Dec 20106Jan 201143Feb 201140Mar 201144Apr 201144May 201130Jun 201127Jul 201123Aug 201140Sep 201144

FY 2012 YTD: 85

Oct 201125Nov 201128Dec 201132Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012