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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 - 2011

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TimeTargetNumber of Meetings
Oct 2010N/A13
Nov 2010N/A18
Dec 2010N/A20
Jan 2011N/A4
Feb 2011N/A9
Mar 2011N/A8
Apr 2011N/A25
May 2011N/A9
Jun 2011N/A5
Jul 2011N/A4
Aug 2011N/A6
Sep 2011N/A9

FY 2011 Total: 130

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.