Main An approval letter is the document used to communicate CBER’s approval of original and supplemental biologics license applications (BLAs) or new drug application (NDAs). OCOD is responsible for ensuring CBER approval letters are reviewed for disclosure and posted on the agency's web site to conform to all pertinent requirements. Expedient posting of approval letters will provide up to date information to the public. <i>Information is current as of March 31, 2013</i> (1) Beginning October 2012, this measure will be reported quarterly Percent column 0 100

FY 2011 Overall: 100%

Jan 2011 90 100 Feb 2011 90 100 Mar 2011 90 100 Apr 2011 90 100 May 2011 90 100 Jun 2011 90 100 Jul 2011 90 100 Aug 2011 90 100 Sep 2011 90 100 0 100

FY 2012 Overall: 100%

Oct 2011 90 100 Nov 2011 90 100 Dec 2011 90 100 Jan 2012 90 100 Feb 2012 90 100 Mar 2012 90 100 Apr 2012 90 100 May 2012 90 100 Jun 2012 90 100 Jul 2012 90 100 Aug 2012 90 100 Sep 2012 90 100 0 100

FY 2013 YTD: 100%

October – December 2012 90 100 January – March 2013 90 100 April – June 2013 90 July – September 2013 90 Sub Percentage of approval letters reviewed for disclosure and posted on the web within 5 business days of receipt in OCOD, excluding days that the Web Content Management System (WCMS) is not operational. (1) Number column

FY 2011 Total: 49

Jan 2011 10 Feb 2011 3 Mar 2011 5 Apr 2011 4 May 2011 5 Jun 2011 8 Jul 2011 10 Aug 2011 2 Sep 2011 2

FY 2012 Total: 59

Oct 2011 3 Nov 2011 0 Dec 2011 5 Jan 2012 8 Feb 2012 3 Mar 2012 14 Apr 2012 2 May 2012 5 Jun 2012 4 Jul 2012 9 Aug 2012 1 Sep 2012 5 0

FY 2013 YTD: 21

October – December 2012 12 January – March 2013 9 April – June 2013 July – September 2013 Sub Percentage of approval letters reviewed for disclosure and posted on the web within 5 business days of receipt in OCOD, excluding days that the Web Content Management System (WCMS) is not operational. (1) Number column

FY 2011 Total: 49

Jan 2011 10 Feb 2011 3 Mar 2011 5 Apr 2011 4 May 2011 5 Jun 2011 8 Jul 2011 10 Aug 2011 2 Sep 2011 2

FY 2012 Total: 59

Oct 2011 3 Nov 2011 0 Dec 2011 5 Jan 2012 8 Feb 2012 3 Mar 2012 14 Apr 2012 2 May 2012 5 Jun 2012 4 Jul 2012 9 Aug 2012 1 Sep 2012 5 0

FY 2013 YTD: 21

October – December 2012 12 January – March 2013 9 April – June 2013 July – September 2013 Sub Percentage of approval letters reviewed for disclosure and posted on the web within 5 business days of receipt in OCOD, excluding days that the Web Content Management System (WCMS) is not operational. (1) Number column 15

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 15

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 15

FY 2013 YTD: 0

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