MainA Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs. The information contained in the DMF may be used to support an Investigational New Drug Application (IND) or New Drug Application (NDA). The review of DMFs only occur in conjunction with an IND, NDA, or NDA supplement review. <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> Number

FY 2010 Total: 490

Oct 200952Nov 200932Dec 200935Jan 201039Feb 201027Mar 201066Apr 201023May 201029Jun 201045Jul 201039Aug 201048Sep 201055

FY 2011 Total: 473

Oct 201019Nov 201038Dec 201030Jan 201150Feb 201141Mar 201131Apr 201142May 201137Jun 201151Jul 201130Aug 201154Sep 201150

FY 2012 YTD: 89

Oct 201128Nov 201131Dec 201130Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboard