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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 - 2012

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TimeTargetNumber of Reviews
Oct 2011N/A5
Nov 2011N/A13
Dec 2011N/A6
Jan 2012N/A17
Feb 2012N/A1
Mar 2012N/A23
Apr 2012N/A20
May 2012N/A0
Jun 2012N/A5
Jul 2012N/A19
Aug 2012N/A8
Sep 2012N/A16

FY 2012 Total: 133


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.