Main These measures show the number of new requirements and commitments established in the quarter that are required for safety or requested by FDA, and the number of PMRs or PMCs fulfilled or released during the quarter. PMRs and PMCs are required or agreed-upon studies or trials conducted after the approval of a marketing application. <i>Information is current as of March 31, 2013</i> (1) Beginning October 2012, this measure will be reported quarterly Number column

Jul 2010 20 Aug 2010 8 Sep 2010 4

FY 2011 Total: 112

Oct 2010 15 Nov 2010 4 Dec 2010 12 Jan 2011 9 Feb 2011 10 Mar 2011 8 Apr 2011 7 May 2011 3 Jun 2011 10 Jul 2011 15 Aug 2011 16 Sep 2011 3

FY 2012 Total: 159

Oct 2011 8 Nov 2011 13 Dec 2011 7 Jan 2012 4 Feb 2012 34 Mar 2012 21 Apr 2012 15 May 2012 16 Jun 2012 17 Jul 2012 6 Aug 2012 2 Sep 2012 16 0

FY 2013 YTD: 85

October – December 2012 40 January – March 2013 45 April – June 2013 July – September 2013 Main (1) Beginning October 2012, this measure will be reported quarterly Number column 0 25

Jul 2010 2 Aug 2010 9 Sep 2010 18 0 25

FY 2011 Total: 89

Oct 2010 7 Nov 2010 7 Dec 2010 7 Jan 2011 3 Feb 2011 12 Mar 2011 8 Apr 2011 9 May 2011 10 Jun 2011 4 Jul 2011 8 Aug 2011 4 Sep 2011 10 0 25

FY 2012 Total: 93

Oct 2011 5 Nov 2011 15 Dec 2011 15 Jan 2012 6 Feb 2012 7 Mar 2012 15 Apr 2012 14 May 2012 2 Jun 2012 2 Jul 2012 1 Aug 2012 6 Sep 2012 5 0 50

FY 2013 YTD: 39

October – December 2012 19 January – March 2013 20 April – June 2013 July – September 2013 http://www.fda.gov/AboutFDA/Transparency/track/ucm206804.htm FDA-TRACK CBER Dashboard word text word defintion ਍††਍਍਍਍਍਍਍