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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 June 30, 2014.

Fiscal Year - 2010

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TimeTargetNumber of Reviews
Oct 2009N/A15
Nov 2009N/A5
Dec 2009N/A6
Jan 2010N/A13
Feb 2010N/A1
Mar 2010N/A10
Apr 2010N/A11
May 2010N/A8
Jun 2010N/A7
Jul 2010N/A3
Aug 2010N/A5
Sep 2010N/A13

FY 2010 Total: 97

Glossary

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.