Main Pediatric labeling changes for drug and biological products trigger mandated safety reviews for adverse events that may occur in children. Three pediatric advisory committee (PAC) meetings are held each year to hear these safety reviews, discuss the findings, and make recommendations to FDA. In 2010, pediatric safety reviews presented to the PAC have now been expanded to include blood products and vaccines. The safety reviews are the basis of the issues meetings which define much of the above PAC agenda. <i>Information is current as of December 31, 2012.</i> Number of Reviews column

FY 2010 Total: 97

Oct 2009 15 Nov 2009 5 Dec 2009 6 Jan 2010 13 Feb 2010 1 Mar 2010 10 Apr 2010 11 May 2010 8 Jun 2010 7 Jul 2010 3 Aug 2010 5 Sep 2010 13

FY 2011 Total: 85

Oct 2010 7 Nov 2010 12 Dec 2010 8 Jan 2011 0 Feb 2011 2 Mar 2011 2 Apr 2011 8 May 2011 4 Jun 2011 3 Jul 2011 19 Aug 2011 14 Sep 2011 6

FY 2012 Total: 133

Oct 2011 5 Nov 2011 13 Dec 2011 6 Jan 2012 17 Feb 2012 1 Mar 2012 23 Apr 2012 20 May 2012 0 Jun 2012 5 Jul 2012 19 Aug 2012 8 Sep 2012 16

FY 2013 YTD: 19

Oct 2012 10 Nov 2012 5 Dec 2012 4 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 ਍††਍਍਍਍਍਍਍