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Total number of orphan drug designation reviews completed in the month
Dictionary: OOPD will track the time it takes to complete the review of each Orphan Drug designation application. OOPD’s goal is to provide all applicants with a complete and comprehensive review in a timely manner by monitoring the incoming workload and allocating resources as needed. The target review percentages per the noted review periods will continue to ensure high quality service to OOPD orphan drug applicant customers.
Information is current as of December 31, 2012.
Fiscal Year - 2011
| Time | Target | Number of Reviews |
|---|---|---|
| Oct 2010 | N/A | 24 |
| Nov 2010 | N/A | 47 |
| Dec 2010 | N/A | 54 |
| Jan 2011 | N/A | 21 |
| Feb 2011 | N/A | 38 |
| Mar 2011 | N/A | 44 |
| Apr 2011 | N/A | 42 |
| May 2011 | N/A | 16 |
| Jun 2011 | N/A | 45 |
| Jul 2011 | N/A | 16 |
| Aug 2011 | N/A | 23 |
| Sep 2011 | N/A | 41 |
FY 2011 Total: 411
Number of reviews of first-time orphan drug designation applications completed in the month
Fiscal Year - 2011
| Time | Target | Number of Reviews |
|---|---|---|
| Oct 2010 | N/A | 18 |
| Nov 2010 | N/A | 36 |
| Dec 2010 | N/A | 45 |
| Jan 2011 | N/A | 18 |
| Feb 2011 | N/A | 30 |
| Mar 2011 | N/A | 32 |
| Apr 2011 | N/A | 33 |
| May 2011 | N/A | 13 |
| Jun 2011 | N/A | 29 |
| Jul 2011 | N/A | 14 |
| Aug 2011 | N/A | 20 |
| Sep 2011 | N/A | 31 |
FY 2011 Total: 319
Number of reviews of amended orphan drug designation applications completed in the month
Fiscal Year - 2011
| Time | Target | Number of Reviews |
|---|---|---|
| Oct 2010 | N/A | 6 |
| Nov 2010 | N/A | 11 |
| Dec 2010 | N/A | 9 |
| Jan 2011 | N/A | 3 |
| Feb 2011 | N/A | 8 |
| Mar 2011 | N/A | 12 |
| Apr 2011 | N/A | 9 |
| May 2011 | N/A | 3 |
| Jun 2011 | N/A | 16 |
| Jul 2011 | N/A | 2 |
| Aug 2011 | N/A | 3 |
| Sep 2011 | N/A | 10 |
FY 2011 Total: 92
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.
