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Number of efficacy supplements received in the month
Dictionary: Efficacy Supplements to NDAs and BLAs are applications to make a change (e.g., add a new indication) to an approved marketing application. These supplements have legislatively mandated timelines for review.
These measures has been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 16 |
| Nov 2011 | N/A | 11 |
| Dec 2011 | N/A | 21 |
| Jan 2012 | N/A | TBD |
| Feb 2012 | N/A | TBD |
| Mar 2012 | N/A | TBD |
| Apr 2012 | N/A | TBD |
| May 2012 | N/A | TBD |
| Jun 2012 | N/A | TBD |
| Jul 2012 | N/A | TBD |
| Aug 2012 | N/A | TBD |
| Sep 2012 | N/A | TBD |
FY 2012 YTD: 48
Total number of actions taken on efficacy supplements during the month
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 9 |
| Nov 2011 | N/A | 6 |
| Dec 2011 | N/A | 7 |
| Jan 2012 | N/A | TBD |
| Feb 2012 | N/A | TBD |
| Mar 2012 | N/A | TBD |
| Apr 2012 | N/A | TBD |
| May 2012 | N/A | TBD |
| Jun 2012 | N/A | TBD |
| Jul 2012 | N/A | TBD |
| Aug 2012 | N/A | TBD |
| Sep 2012 | N/A | TBD |
FY 2012 YTD: 22
Number of actions taken on efficacy supplements in the month that were within goal dates
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 9 |
| Nov 2011 | N/A | 6 |
| Dec 2011 | N/A | 6 |
| Jan 2012 | N/A | TBD |
| Feb 2012 | N/A | TBD |
| Mar 2012 | N/A | TBD |
| Apr 2012 | N/A | TBD |
| May 2012 | N/A | TBD |
| Jun 2012 | N/A | TBD |
| Jul 2012 | N/A | TBD |
| Aug 2012 | N/A | TBD |
| Sep 2012 | N/A | TBD |
FY 2012 YTD: 21
Number of actions taken on efficacy supplements in the month that were past goal dates
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 0 |
| Nov 2011 | N/A | 0 |
| Dec 2011 | N/A | 1 |
| Jan 2012 | N/A | TBD |
| Feb 2012 | N/A | TBD |
| Mar 2012 | N/A | TBD |
| Apr 2012 | N/A | TBD |
| May 2012 | N/A | TBD |
| Jun 2012 | N/A | TBD |
| Jul 2012 | N/A | TBD |
| Aug 2012 | N/A | TBD |
| Sep 2012 | N/A | TBD |
FY 2012 YTD: 1
For those actions taken past goal deadlines, median number of days past the goal date
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 0 |
| Nov 2011 | N/A | 0 |
| Dec 2011 | N/A | 121 |
| Jan 2012 | N/A | TBD |
| Feb 2012 | N/A | TBD |
| Mar 2012 | N/A | TBD |
| Apr 2012 | N/A | TBD |
| May 2012 | N/A | TBD |
| Jun 2012 | N/A | TBD |
| Jul 2012 | N/A | TBD |
| Aug 2012 | N/A | TBD |
| Sep 2012 | N/A | TBD |
Number of overdue efficacy supplements at the end of the month
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 9 |
| Nov 2011 | N/A | 14 |
| Dec 2011 | N/A | 12 |
| Jan 2012 | N/A | TBD |
| Feb 2012 | N/A | TBD |
| Mar 2012 | N/A | TBD |
| Apr 2012 | N/A | TBD |
| May 2012 | N/A | TBD |
| Jun 2012 | N/A | TBD |
| Jul 2012 | N/A | TBD |
| Aug 2012 | N/A | TBD |
| Sep 2012 | N/A | TBD |
FY 2012 YTD: 35
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.
