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Number of medical products studied in children with pediatric safety labeling changes in the month
Dictionary: The number of Food and Drug Administration Amendments Act (FDAAA) pediatric labeling changes per month that must have safety reporting to the Pediatric Advisory Committee (PAC). (This is not the number of products but rather the number of labeling changes. A product can have more than one labeling change. If so, it is counted as two labeling changes.)
Information is current as of December 31, 2012.
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 2 |
| Nov 2011 | N/A | 2 |
| Dec 2011 | N/A | 5 |
| Jan 2012 | N/A | 3 |
| Feb 2012 | N/A | 1 |
| Mar 2012 | N/A | 5 |
| Apr 2012 | N/A | 2 |
| May 2012 | N/A | 3 |
| Jun 2012 | N/A | 1 |
| Jul 2012 | N/A | 0 |
| Aug 2012 | N/A | 5 |
| Sep 2012 | N/A | 2 |
FY 2012 Total: 31
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.
