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Number of NDA supplement (sNDA) reviews completed and signed off within the month
Dictionary: The number of sNDA and sBLA reviews, for therapeutic protein and monoclonal antibody products, completed and signed off by OBP within the month. Includes all IQA reviews, primary reviews, summary and/or executive reviews. These reviews evaluate the impact of manufacturing changes on the quality of marketed products. These reviews cover quality related aspects of safety including immunogenicity.
These measures have 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 - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 1 |
| Nov 2010 | N/A | 3 |
| Dec 2010 | N/A | 3 |
| Jan 2011 | N/A | 2 |
| Feb 2011 | N/A | 5 |
| Mar 2011 | N/A | 0 |
| Apr 2011 | N/A | 3 |
| May 2011 | N/A | 3 |
| Jun 2011 | N/A | 1 |
| Jul 2011 | N/A | 3 |
| Aug 2011 | N/A | 3 |
| Sep 2011 | N/A | 3 |
FY 2011 Total: 30
Number of BLA supplement (sBLA) reviews completed and signed off within the month
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 4 |
| Nov 2010 | N/A | 13 |
| Dec 2010 | N/A | 6 |
| Jan 2011 | N/A | 43 |
| Feb 2011 | N/A | 40 |
| Mar 2011 | N/A | 44 |
| Apr 2011 | N/A | 44 |
| May 2011 | N/A | 30 |
| Jun 2011 | N/A | 27 |
| Jul 2011 | N/A | 23 |
| Aug 2011 | N/A | 40 |
| Sep 2011 | N/A | 44 |
FY 2011 Total: 358
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.
