Main Efficacy Supplements to New Drug Applications (NDAs), Biologics License Applications (BLAs), Post Marketing Application (PMA) Panel Track, Abbreviated New Drug Application (ANDAs) and Biosimilar Biological Product Applications (BBPAs) are submissions that will make a change to an approved marketing application. This change may include a new or expanded indication, new routes of administration, revisions to the dosage or dosing regimen, or improved safety. This measure track’s CBER’s performance in issuing decisions within established timeframes. (1) Beginning October 2012, this measure will be reported quarterly Number column

Jul 2010 2 Aug 2010 2 Sep 2010 4

FY 2011 Total: 15

Oct 2010 1 Nov 2010 1 Dec 2010 4 Jan 2011 1 Feb 2011 1 Mar 2011 1 Apr 2011 2 May 2011 1 Jun 2011 1 Jul 2011 1 Aug 2011 1 Sep 2011 0

FY 2012 Total: 15

Oct 2011 0 Nov 2011 0 Dec 2011 5 Jan 2012 0 Feb 2012 1 Mar 2012 2 Apr 2012 0 May 2012 2 Jun 2012 1 Jul 2012 2 Aug 2012 1 Sep 2012 1 0

FY 2013 YTD: 5

October – December 2012 5 January – March 2013 April – June 2013 July – September 2013 Main (1) Beginning October 2012, this measure will be reported quarterly. Number column 0 5

Jul 2010 0 Aug 2010 0 Sep 2010 0 0 5

FY 2011 Total: 0

Oct 2010 0 Nov 2010 0 Dec 2010 0 Jan 2011 0 Feb 2011 0 Mar 2011 0 Apr 2011 0 May 2011 0 Jun 2011 0 Jul 2011 0 Aug 2011 0 Sep 2011 0 0 5

FY 2012 Total: 0

Oct 2011 0 Nov 2011 0 Dec 2011 0 Jan 2012 0 Feb 2012 0 Mar 2012 0 Apr 2012 0 May 2012 0 Jun 2012 0 Jul 2012 0 Aug 2012 0 Sep 2012 0 0

FY 2013 YTD: 0

October – December 2012 0 January – March 2013 April – June 2013 July – September 2013 http://www.fda.gov/AboutFDA/Transparency/track/ucm206804.htm FDA-TRACK CBER Dashboard word text word defintion ਍††਍਍਍਍਍਍਍