Main Licensed manufacturers must submit a prior approval supplement to FDA for any change to a product that has a substantial impact to have an adverse effect on the identity, strength, quality, purity or potency of the product as they may relate to the safety or effectiveness of the product. Examples of such changes include production process, quality controls, equipment, facilities, or responsible personnel. FDA approval must be obtained prior to distribution of the product made with the change. This measure will allow OVRR to monitor its performance in issuing decisions for manufacturing supplements requiring prior approval within established timeframes. <i>Information is current as of September 30, 2012</i> (1) OVRR revised this measure from standard efficacy supplements to BLA manufacturing supplements based on revised FDA-TRACK program guidance. Tracking against this measure did not begin until April 2010. Percent column 0 100

FY 2010 6-month Overall: 100%

Apr 2010 90 100 May 2010 90 100 Jun 2010 90 100 Jul 2010 90 100 Aug 2010 90 100 Sep 2010 90 100 0 100

FY 2011 Overall: 100%

Oct 2010 90 100 Nov 2010 90 100 Dec 2010 90 100 Jan 2011 90 100 Feb 2011 90 100 Mar 2011 90 100 Apr 2011 90 100 May 2011 90 100 Jun 2011 90 100 Jul 2011 90 100 Aug 2011 90 100 Sep 2011 90 100 0 100

FY 2012 Overall: 100%

Oct 2011 90 100 Nov 2011 90 100 Dec 2011 90 100 Jan 2012 90 100 Feb 2012 90 100 Mar 2012 90 100 Apr 2012 90 100 May 2012 90 100 Jun 2012 90 100 Jul 2012 90 100 Aug 2012 90 100 Sep 2012 90 100 Sub Percentage of Biologics License Application (BLA) manufacturing supplements with action due dates occurring during the month that were reviewed and acted upon within 4 months of receipt (1) Number column

FY 2010 6-month Total: 40

Apr 2010 10 May 2010 7 Jun 2010 9 Jul 2010 7 Aug 2010 2 Sep 2010 5

FY 2011 Total: 104

Oct 2010 6 Nov 2010 3 Dec 2010 9 Jan 2011 2 Feb 2011 3 Mar 2011 11 Apr 2011 13 May 2011 4 Jun 2011 16 Jul 2011 12 Aug 2011 16 Sep 2011 9

FY 2012 Total: 92

Oct 2011 8 Nov 2011 8 Dec 2011 6 Jan 2012 1 Feb 2012 7 Mar 2012 19 Apr 2012 8 May 2012 5 Jun 2012 3 Jul 2012 6 Aug 2012 7 Sep 2012 14 Sub Percentage of Biologics License Application (BLA) manufacturing supplements with action due dates occurring during the month that were reviewed and acted upon within 4 months of receipt (1) Number column

FY 2010 6-month Total: 40

Apr 2010 10 May 2010 7 Jun 2010 9 Jul 2010 7 Aug 2010 2 Sep 2010 5

FY 2011 Total: 104

Oct 2010 6 Nov 2010 3 Dec 2010 9 Jan 2011 2 Feb 2011 3 Mar 2011 11 Apr 2011 13 May 2011 4 Jun 2011 16 Jul 2011 12 Aug 2011 16 Sep 2011 9

FY 2012 Total: 92

Oct 2011 8 Nov 2011 8 Dec 2011 6 Jan 2012 1 Feb 2012 7 Mar 2012 19 Apr 2012 8 May 2012 5 Jun 2012 3 Jul 2012 6 Aug 2012 7 Sep 2012 14 http://www.fda.gov/AboutFDA/Transparency/track/ucm206804.htm FDA-TRACK CBER Dashboard word text word defintion ਍††਍਍਍਍਍਍਍