MainThe FDA receives hundreds of thousands of AE reports each year. The AE reports are monitored very closely to determine whether or not a serious safety signal is observed and whether a regulatory action might be necessary. <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> Number50100

Oct 200943,365Nov 200955,704Dec 200966,559Jan 201052,107Feb 201048,712Mar 201057,008Apr 201054,236May 201049,658Jun 201056,826Jul 201085,479Aug 201070,455Sep 201067,208

FY 2011 Total: 841,513

Oct 201056,915Nov 201064,974Dec 201082,822Jan 201165,235Feb 201158,558Mar 201175,200Apr 201169,325May 201170,655Jun 201175,374Jul 201171,882Aug 201177,475Sep 201173,098

FY 2012 YTD: 233,171

Oct 201172,092Nov 201181,855Dec 201179,224Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER DashboardMainThe FDA receives hundreds of thousands of AE reports each year. The AE reports are monitored very closely to determine whether or not a serious safety signal is observed and whether a regulatory action might be necessary.Percent50100

Oct 200972Nov 200959Dec 200971Jan 201061Feb 201073Mar 201075Apr 201064May 201071Jun 201079Jul 201085Aug 201079Sep 201081

Oct 201081Nov 201073Dec 201079Jan 201181Feb 201180Mar 201175Apr 201176May 201179Jun 201181Jul 201168Aug 201182Sep 201181

Oct 201184Nov 201180Dec 201174Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012