MainIn the course of the review of IND, NDA, or supplemental NDA submissions, interactions with the sponsor or applicant is beneficial to request additional information, clarify information submitted in the application, and communicate decisions made regarding the application. These correspondences include all communications by ONDQA staff, either written or orally communicated, associated with the review of chemistry, manufacturing, and controls information submitted in IND, NDA, supplemental NDA, or DMF submissions. <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) These official documents and correspondences include, but are not limited to, information requests and advice communications (either written or orally communicated), as well as action letters.Number

FY 2010 Total: 3,127

Oct 2009307Nov 2009243Dec 2009289Jan 2010246Feb 2010229Mar 2010300Apr 2010317May 2010237Jun 2010251Jul 2010223Aug 2010246Sep 2010239

FY 2011 Total: 2,832

Oct 2010202Nov 2010185Dec 2010175Jan 2011278Feb 2011216Mar 2011257Apr 2011239May 2011232Jun 2011259Jul 2011209Aug 2011352Sep 2011228

FY 2012 YTD: 845

Oct 2011254Nov 2011229Dec 2011362Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboard