MainNumber of OBP product manufacturing facilities site inspections which occurred during the month. OBP review staff participates in most pre-approval inspections and many surveillance inspections of manufacturing facilities. For complex products, such as therapeutic protein and monoclonal antibody products, it is important for OBP reviewers to participate in the assessment of the manufacturing process and controls at the facility. <br>These measures have 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> Number0

Oct 20095Nov 20095Dec 20090Jan 20102Feb 20102Mar 20103Apr 20102May 20102Jun 20101Jul 20100Aug 20101Sep 201010

FY 2011 Total: 17

Oct 20104Nov 20103Dec 20100Jan 20110Feb 20112Mar 20111Apr 20111May 20114Jun 20112Jul 20110Aug 20110Sep 201100

FY 2012 YTD: 3

Oct 20112Nov 20110Dec 20111Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER DashboardMainNumber of pre-, post-, and during inspection meetings with ORA and CDER’s Office of Compliance (OC) Division of Manufacturing and Product Quality (DMPQ) which occurred during the month. For complex products, such as therapeutic protein and monoclonal antibody products, it is important for OBP reviewers to participate in the assessment of the manufacturing process and controls at the facility. This participation involves meetings. In addition, for facilities where OBP does not participate in the inspection, meetings convey issues to be considered during inspections.Number0

Oct 20099Nov 20094Dec 20090Jan 20102Feb 20106Mar 20106Apr 201010May 20101Jun 20107Jul 20102Aug 20102Sep 201010

FY 2011 Total: 14

Oct 20102Nov 20100Dec 20100Jan 20110Feb 20110Mar 20112Apr 20112May 20113Jun 20112Jul 20112Aug 20111Sep 201100

FY 2012 YTD: 1

Oct 20110Nov 20110Dec 20111Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012 ਍††਍਍਍਍਍਍਍