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Number of IND submissions and amendments evaluated and signed off within the month
Dictionary: Database tracking of the number of IND submissions and amendments, for therapeutic protein and monoclonal antibody products, evaluated and signed off by OBP within the month. These are submissions that have had an evaluation by OBP reviewers to ensure there are no issues that impact product quality and related safety concerns.
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 | 366 |
| Nov 2010 | N/A | 269 |
| Dec 2010 | N/A | 679 |
| Jan 2011 | N/A | 762 |
| Feb 2011 | N/A | 787 |
| Mar 2011 | N/A | 856 |
| Apr 2011 | N/A | 1,077 |
| May 2011 | N/A | 925 |
| Jun 2011 | N/A | 1,877 |
| Jul 2011 | N/A | 1,271 |
| Aug 2011 | N/A | 1,467 |
| Sep 2011 | N/A | 945 |
FY 2011 Total: 11,291
Number of IND reviews completed and signed off within the month
Dictionary: Database tracking of the number IND reviews, for therapeutic protein and monoclonal antibody products, completed and signed off by OBP within the month. Includes all 30-day safety reviews, summary and executive reviews, and reviews of manufacturing changes and new study requests. These reviews support the quality and safety of investigational new drugs and significant manufacturing changes during development.
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 65 |
| Nov 2010 | N/A | 49 |
| Dec 2010 | N/A | 89 |
| Jan 2011 | N/A | 66 |
| Feb 2011 | N/A | 94 |
| Mar 2011 | N/A | 99 |
| Apr 2011 | N/A | 99 |
| May 2011 | N/A | 81 |
| Jun 2011 | N/A | 121 |
| Jul 2011 | N/A | 115 |
| Aug 2011 | N/A | 96 |
| Sep 2011 | N/A | 105 |
FY 2011 Total: 1,079
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.
