Main This measure shows marketing applications receipts and various actions taken in month. It provides a workload perspective. Marketing Applications (BLA, NDA, PMA, and Premarket Notifications (510(k)) are applications to request permission to market a product in the U.S. for a specific use. This measure tracks CBER’s performance in issuing decisions within established timeframes. <Information is current as of March 31, 2013</i> (1) Beginning in October 2012, this measure will be tracked quarterly (2) Actions include approval, denial, refusal to file, withdrawal, and complete response for BLAs and NDAs, additional information, determination of substantially equivalent, determination of not substantially equivalent for 510(k)s, and approval, approvable, not approvable, withdrawal, denial, refusal to file and major deficiency for PMAs. Number column

Jul 2010 14 Aug 2010 10 Sep 2010 4

FY 2011 Total: 110

Oct 2010 13 Nov 2010 11 Dec 2010 8 Jan 2011 4 Feb 2011 11 Mar 2011 4 Apr 2011 7 May 2011 5 Jun 2011 10 Jul 2011 8 Aug 2011 11 Sep 2011 18

FY 2012 Total: 132

Oct 2011 9 Nov 2011 9 Dec 2011 12 Jan 2012 8 Feb 2012 11 Mar 2012 13 Apr 2012 12 May 2012 12 Jun 2012 12 Jul 2012 11 Aug 2012 15 Sep 2012 8 0

FY 2013 YTD: 55

October – December 2012 55 January – March 2013 April – June 2013 July – September 2013 Main (1) Beginning October 2012, this measure will be reported quarterly (2) Actions include approval, denial, refusal to file, withdrawal, and complete response for BLAs and NDAs, additional information, determination of substantially equivalent, determination of not substantially equivalent for 510(k)s, and approval, approvable, not approvable, withdrawal, denial, refusal to file and major deficiency for PMAs. Number column

Jul 2010 14 Aug 2010 9 Sep 2010 4

FY 2011 Total: 110

Oct 2010 13 Nov 2010 11 Dec 2010 8 Jan 2011 4 Feb 2011 11 Mar 2011 4 Apr 2011 7 May 2011 5 Jun 2011 10 Jul 2011 8 Aug 2011 11 Sep 2011 18

FY 2012 Total: 132

Oct 2011 9 Nov 2011 9 Dec 2011 12 Jan 2012 8 Feb 2012 11 Mar 2012 13 Apr 2012 12 May 2012 12 Jun 2012 12 Jul 2012 11 Aug 2012 15 Sep 2012 8 0

FY 2013 YTD: 55

October – December 2012 55 January – March 2013 April – June 2013 July – September 2013 Main (2) Actions include approval, denial, refusal to file, withdrawal, and complete response for BLAs and NDAs, additional information, determination of substantially equivalent, determination of not substantially equivalent for 510(k)s, and approval, approvable, not approvable, withdrawal, denial, refusal to file and major deficiency for PMAs. Number column 0 15

Jul 2010 0 Aug 2010 1 Sep 2010 0 0 15

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 15

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 ਍††਍਍਍਍਍਍਍