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Percentage of orphan drug designation reviews completed in 120 days or less
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 - 2010
| Time | Target | Percentage |
|---|---|---|
| Oct 2009 | N/A | N/A |
| Nov 2009 | N/A | N/A |
| Dec 2009 | 90 | 93 |
| Jan 2010 | 90 | 100 |
| Feb 2010 | 90 | 82 |
| Mar 2010 | 90 | 94 |
| Apr 2010 | 90 | 100 |
| May 2010 | 90 | 96 |
| Jun 2010 | 90 | 96 |
| Jul 2010 | 90 | 88 |
| Aug 2010 | 90 | 97 |
| Sep 2010 | 90 | 100 |
FY 2010 10-Month Overall: 81%
Total number of orphan drug designation reviews completed in 120 days or less
Fiscal Year - 2010
| Time | Target | Number of Reviews |
|---|---|---|
| Oct 2009 | N/A | N/A |
| Nov 2009 | N/A | N/A |
| Dec 2009 | N/A | 26 |
| Jan 2010 | N/A | 10 |
| Feb 2010 | N/A | 18 |
| Mar 2010 | N/A | 30 |
| Apr 2010 | N/A | 30 |
| May 2010 | N/A | 27 |
| Jun 2010 | N/A | 27 |
| Jul 2010 | N/A | 7 |
| Aug 2010 | N/A | 30 |
| Sep 2010 | N/A | 45 |
FY 2010 10-Month Total: 250
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.
