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U.S. Department of Health and Human Services

About FDA

Number of pediatric safety reviews completed (BPCA, PREA, and Pediatric Rule)

Dictionary: In accordance with the Best Pharmaceuticals for Children Act (BPCA) or the Pediatric Research Equity Act (PREA) or both, OSE summarizes post-marketing reports of adverse events associated with the use of products in pediatric patients (0-16 years of age).  The main focus of the reviews are pediatric deaths and pediatric reports of serious unlabeled events.

Information is current as of March 31, 2015.

Fiscal Year - 2014

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Oct 2013N/A1
Nov 2013N/A7
Dec 2013N/A2
Jan 2014N/A1
Feb 2014N/A0
Mar 2014N/A0
Apr 2014N/A0
May 2014N/A0
Jun 2014N/A0
Jul 2014N/A2
Aug 2014N/A7
Sep 2014N/A2

FY 2014 Total: 22


  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.


Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.