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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 March 31, 2014.

Fiscal Year - 2012

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TimeTargetNumber of Meetings
Oct 2011N/A9
Nov 2011N/A5
Dec 2011N/A3
Jan 2012N/A8
Feb 2012N/A6
Mar 2012N/A6
Apr 2012N/A2
May 2012N/A10
Jun 2012N/A12
Jul 2012N/A7
Aug 2012N/A10
Sep 2012N/A5

FY 2012 Total: 83

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.