MainThese totals reflect a composite number of genomic reviews completed per month for submissions including, but not limited to the following: a) Investigational New Drug (IND) submissions (including protocols, meeting packages, and clinical study reports), b) Biologics License Application (BLA) submissions, c) New Drug Application (NDA) submissions (including original applications, supplements, and post-marketing commitment/requirement reports), and d) Investigational Device Exemptions (IDEs). <br>This measure 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> (1) PDUFA reviews are captured by ONDNumber

Oct 200913Nov 200914Dec 20098Jan 201010Feb 20105Mar 201021Apr 201019May 201013Jun 201010Jul 201018Aug 20105Sep 20105

FY 2011 Total: 114

Oct 20108Nov 20108Dec 201010Jan 201113Feb 20118Mar 20116Apr 201113May 20118Jun 201110Jul 201114Aug 201110Sep 20116

FY 2012 YTD: 30

Oct 201112Nov 20118Dec 201110Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboard