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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 - 2012

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Oct 2011N/AN/A
Nov 2011N/AN/A
Dec 2011N/AN/A
Jan 2012N/AN/A
Feb 2012N/AN/A
Mar 2012N/AN/A
Apr 2012N/AN/A
May 2012N/AN/A
Jun 2012N/AN/A
Jul 2012N/A3
Aug 2012N/A0
Sep 2012N/A1

FY 2012 3 month Total: 4


  • 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.