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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 December 31, 2012.
Fiscal Year - 2012
| Time | Target | Number of Meetings |
|---|---|---|
| Oct 2011 | N/A | 9 |
| Nov 2011 | N/A | 5 |
| Dec 2011 | N/A | 3 |
| Jan 2012 | N/A | 8 |
| Feb 2012 | N/A | 6 |
| Mar 2012 | N/A | 6 |
| Apr 2012 | N/A | 2 |
| May 2012 | N/A | 10 |
| Jun 2012 | N/A | 12 |
| Jul 2012 | N/A | 7 |
| Aug 2012 | N/A | 10 |
| Sep 2012 | N/A | 5 |
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.
