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Number of efficacy supplements received in the quarter (1)
Dictionary: Efficacy Supplements to New Drug Applications (NDAs), Biologics License Applications (BLAs), Post Marketing Application (PMA) Panel Track, Abbreviated New Drug Application (ANDAs) and Biosimilar Biological Product Applications (BBPAs) are submissions that will make a change to an approved marketing application. This change may include a new or expanded indication, new routes of administration, revisions to the dosage or dosing regimen, or improved safety. This measure track’s CBER’s performance in issuing decisions within established timeframes.
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 1 |
| Nov 2010 | N/A | 1 |
| Dec 2010 | N/A | 4 |
| Jan 2011 | N/A | 1 |
| Feb 2011 | N/A | 1 |
| Mar 2011 | N/A | 1 |
| Apr 2011 | N/A | 2 |
| May 2011 | N/A | 1 |
| Jun 2011 | N/A | 1 |
| Jul 2011 | N/A | 1 |
| Aug 2011 | N/A | 1 |
| Sep 2011 | N/A | 0 |
FY 2011 Total: 15
Footnotes
- (1) Beginning October 2012, this measure will be reported quarterly
Number of overdue efficacy supplements at the end of the quarter (1)
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 0 |
| Nov 2010 | N/A | 0 |
| Dec 2010 | N/A | 0 |
| Jan 2011 | N/A | 0 |
| Feb 2011 | N/A | 0 |
| Mar 2011 | N/A | 0 |
| Apr 2011 | N/A | 0 |
| May 2011 | N/A | 0 |
| Jun 2011 | N/A | 0 |
| Jul 2011 | N/A | 0 |
| Aug 2011 | N/A | 0 |
| Sep 2011 | N/A | 0 |
FY 2011 Total: 0
Footnotes
- (1) Beginning October 2012, this measure will be reported quarterly.
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.
