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U.S. Department of Health and Human Services

About FDA

Number of product safety assessment meetings coordinated for public review in the month

Dictionary: 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.

Information is current as of December 31, 2014.

Fiscal Year - 2014

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TimeTargetNumber of Reviews
Oct 2013N/A6
Nov 2013N/A2
Dec 2013N/A3
Jan 2014N/A5
Feb 2014N/A2
Mar 2014N/A1
Apr 2014N/A24
May 2014N/A3
Jun 2014N/A7
Jul 2014N/A7
Aug 2014N/A2
Sep 2014N/A21

FY 2014 Total: 83


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.