MainDrug manufacturers are required to submit to FDA reports of adverse events they receive related to their products. These reports provide crucial information to help enable CDER to monitor the post-market safety of drug products in use. Currently, manufacturers may submit these reports to CDER by mail, fax, or electronically through CDER’s MedWatch portal. As electronic reporting streamlines CDER processes, saves time and money, and ensures quicker reporting, CDER is committed to increasing the proportion of reports submitted electronically. FDA is currently developing an improved web-interface reporting system to be called MedWatch Plus. The MedWatch Plus portal will include a rational questionnaire which will help facilitate improved communication, ease of reporting, and enable more complete and higher quality reporting. This timelier and higher quality reporting will positively affect public heath by enabling improved scientific analysis of adverse event reporting and more timely and accurate detection of safety signals. <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> PercentAnnual TargetFY 2011 Target: 90%

Oct 201089Nov 201089Dec 201089Jan 201188Feb 201189Mar 201190Apr 201188May 201189Jun 201191Jul 201189Aug 201188Sep 201191

Oct 201191Nov 201191Dec 201191Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER DashboardMainDrug manufacturers are required to submit to FDA reports of adverse events they receive related to their products. These reports provide crucial information to help enable CDER to monitor the post-market safety of drug products in use. Currently, manufacturers may submit these reports to CDER by mail, fax, or electronically through CDER’s MedWatch portal. As electronic reporting streamlines CDER processes, saves time and money, and ensures quicker reporting, CDER is committed to increasing the proportion of reports submitted electronically. FDA is currently developing an improved web-interface reporting system to be called MedWatch Plus. The MedWatch Plus portal will include a rational questionnaire which will help facilitate improved communication, ease of reporting, and enable more complete and higher quality reporting. This timelier and higher quality reporting will positively affect public heath by enabling improved scientific analysis of adverse event reporting and more timely and accurate detection of safety signals.Numbercolumn

FY 2011 Total: 434,072

Oct 201031,534Nov 201032,639Dec 201037,126Jan 201130,755Feb 201132,404Mar 201139,279Apr 201136,241May 201137,015Jun 201144,337Jul 201135,695Aug 201139,472Sep 201137,575

FY 2012 YTD: 115,102

Oct 201136,992Nov 201138,850Dec 201139,260Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012MainDrug manufacturers are required to submit to FDA reports of adverse events they receive related to their products. These reports provide crucial information to help enable CDER to monitor the post-market safety of drug products in use. Currently, manufacturers may submit these reports to CDER by mail, fax, or electronically through CDER’s MedWatch portal. As electronic reporting streamlines CDER processes, saves time and money, and ensures quicker reporting, CDER is committed to increasing the proportion of reports submitted electronically. FDA is currently developing an improved web-interface reporting system to be called MedWatch Plus. The MedWatch Plus portal will include a rational questionnaire which will help facilitate improved communication, ease of reporting, and enable more complete and higher quality reporting. This timelier and higher quality reporting will positively affect public heath by enabling improved scientific analysis of adverse event reporting and more timely and accurate detection of safety signals.Percent

Oct 201011Nov 201011Dec 201011Jan 201112Feb 201111Mar 201110Apr 201112May 201111Jun 20119Jul 201111Aug 201112Sep 20119

Oct 20119Nov 20119Dec 20119Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012MainDrug manufacturers are required to submit to FDA reports of adverse events they receive related to their products. These reports provide crucial information to help enable CDER to monitor the post-market safety of drug products in use. Currently, manufacturers may submit these reports to CDER by mail, fax, or electronically through CDER’s MedWatch portal. As electronic reporting streamlines CDER processes, saves time and money, and ensures quicker reporting, CDER is committed to increasing the proportion of reports submitted electronically. FDA is currently developing an improved web-interface reporting system to be called MedWatch Plus. The MedWatch Plus portal will include a rational questionnaire which will help facilitate improved communication, ease of reporting, and enable more complete and higher quality reporting. This timelier and higher quality reporting will positively affect public heath by enabling improved scientific analysis of adverse event reporting and more timely and accurate detection of safety signals.Numbercolumn

FY 2011 Total: 52,248

Oct 20103,776Nov 20104,024Dec 20104,371Jan 20113,998Feb 20114,163Mar 20114,419Apr 20114,738May 20114,732Jun 20114,466Jul 20114,360Aug 20115,618Sep 20113,583

FY 2012 YTD: 11,549

Oct 20113,545Nov 20113,977Dec 20114,027Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012 ਍††਍਍਍਍਍਍਍