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 December 31, 2012.
Fiscal Year - 2013
| Time | Target | Number of Meetings |
|---|---|---|
| Oct 2012 | N/A | 2 |
| Nov 2012 | N/A | 3 |
| Dec 2012 | N/A | 2 |
| Jan 2013 | N/A | TBD |
| Feb 2013 | N/A | TBD |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 7
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.
