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U.S. Department of Health and Human Services

About FDA

Number of internal safety meetings for pediatric products or issues in the month

Dictionary: Each month an assessment of how many products will be eligible for a pediatric focused safety review is identified. The products are then assessed for timing for presentation to the Pediatric Advisory Committee, based on labeling date and extent of possible discussion or other class product issues. A series of meetings involving OSE, the technical division, pediatricians and others are coordinated by OPT to evaluate the known issues, establish responsibilities, timelines and future meetings to further define issues and the advisory committee agenda.

Information is current as of June 30, 2014.

Fiscal Year - 2010

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TimeTargetNumber of Meetings
Oct 2009N/A23
Nov 2009N/A16
Dec 2009N/A11
Jan 2010N/A22
Feb 2010N/A3
Mar 2010N/A16
Apr 2010N/A8
May 2010N/A18
Jun 2010N/A23
Jul 2010N/A7
Aug 2010N/A11
Sep 2010N/A14

FY 2010 Total: 172

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.