MainOnce a drug has been approved for 18-months or has been used by 10,000 patients, whichever is later, a summary analysis of the adverse drug reaction reports received for the drug, including identification of any new risks not previously identified, potential new risks, or known risks reported in unusual number. <br>These measures has 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 20090Nov 20090Dec 20090Jan 20100Feb 20101Mar 20100Apr 20100May 20100Jun 20101Jul 20101Aug 20100Sep 201000

FY 2011 Total: 10

Oct 20100Nov 20101Dec 20100Jan 20112Feb 20112Mar 20113Apr 20112May 20110Jun 20110Jul 20110Aug 20110Sep 20110

FY 2012 YTD: 2

Oct 20110Nov 20110Dec 20112Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboardhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htmPostmarketing Drug Safety EvaluationsMainOnce a drug has been approved for 18-months or has been used by 10,000 patients, whichever is later, a summary analysis of the adverse drug reaction reports received for the drug, including identification of any new risks not previously identified, potential new risks, or known risks reported in unusual number.Number0

Oct 20093Nov 20092Dec 20091Jan 20101Feb 20102Mar 20102Apr 20101May 20101Jun 20103Jul 20101Aug 20102Sep 201000

FY 2011 Total: 17

Oct 20102Nov 20100Dec 20100Jan 20114Feb 20113Mar 20112Apr 20113May 20111Jun 20112Jul 20110Aug 20110Sep 20110

FY 2012 YTD: 12

Oct 20113Nov 20111Dec 20118Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012