MainThese pediatric reviews are a composite number including, but not limited to the following: a) supplemental pediatric studies submitted, b) Pediatric Plans submitted for deferred studies under the Pediatric Research Equity Act (PREA), c) waived or partially waived studies under PREA, and d) Written Requests for pediatric studies issued under the Best Pharmaceuticals for Children Act (BPCA). The PREA and the BPCA were renewed as part of the FDA Amendments Act of 2007 to both protect children from harmful drug effects and to provide the best care possible for children. The performance of the duties related to these acts depends upon careful planning of pediatric studies, and vigilance regarding the interpretation and analysis of pediatric studies already conducted. This due diligence is important so as to not undermine the protection of children's health as provided by the Acts. Therefore the Office of Clinical Pharmacology considers the careful tracking of pediatric studies to be essential to adequately insure the proper treatment of children as intended under PREA and BPCA. <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) PDUFA reviews are captured by ONDNumber

Oct 200925Nov 200910Dec 200914Jan 201018Feb 201019Mar 201032Apr 201019May 201027Jun 201025Jul 201022Aug 201016Sep 201015

FY 2011 Total: 207

Oct 201018Nov 201014Dec 201015Jan 201114Feb 201121Mar 201123Apr 201119May 201117Jun 201118Jul 201121Aug 201115Sep 201112

FY 2012 YTD: 61

Oct 201123Nov 201125Dec 201113Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboard