Main The number of Food and Drug Administration Amendments Act (FDAAA) pediatric labeling changes per month that must have safety reporting to the Pediatric Advisory Committee (PAC). (This is not the number of products but rather the number of labeling changes. A product can have more than one labeling change. If so, it is counted as two labeling changes.) <i>Information is current as of December 31, 2012.</i> Number column

FY 2011 Total: 19

Oct 2010 N/A Nov 2010 N/A Dec 2010 N/A Jan 2011 N/A Feb 2011 2 Mar 2011 2 Apr 2011 6 May 2011 2 Jun 2011 3 Jul 2011 3 Aug 2011 1 Sep 2011 0

FY 2012 Total: 31

Oct 2011 2 Nov 2011 2 Dec 2011 5 Jan 2012 3 Feb 2012 1 Mar 2012 5 Apr 2012 2 May 2012 3 Jun 2012 1 Jul 2012 0 Aug 2012 5 Sep 2012 2

FY 2013 YTD: 8

Oct 2012 4 Nov 2012 2 Dec 2012 2 Jan 2013 Feb 2013 Mar 2013 Apr 2013 May 2013 Jun 2013 Jul 2013 Aug 2013 Sep 2013 http://www.fda.gov/AboutFDA/Transparency/track/ucm206293.htm FDA-TRACK Office of Special Medical Programs Dashboard ਍††਍਍਍਍਍਍਍