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Total submissions routed to drug review
Dictionary: Total submissions routed to the drug review process provides a good summary of workload volume for CDER. Submissions are comprised primarily of New Drug Application (NDA) related submissions, Abbreviated New Drug Application (ANDA) related submissions and Investigational New Drug (IND) related submissions.
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 - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 14,633 |
| Nov 2010 | N/A | 14,312 |
| Dec 2010 | N/A | 15,508 |
| Jan 2011 | N/A | 14,183 |
| Feb 2011 | N/A | 15,282 |
| Mar 2011 | N/A | 17,080 |
| Apr 2011 | N/A | 15,651 |
| May 2011 | N/A | 15,838 |
| Jun 2011 | N/A | 15,944 |
| Jul 2011 | N/A | 15,286 |
| Aug 2011 | N/A | 16,273 |
| Sep 2011 | N/A | 15,755 |
FY 2011 Total: 185,745
Total New Drug Application (NDA) related submissions
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 1,820 |
| Nov 2010 | N/A | 1,791 |
| Dec 2010 | N/A | 2,158 |
| Jan 2011 | N/A | 1,526 |
| Feb 2011 | N/A | 1,932 |
| Mar 2011 | N/A | 1,931 |
| Apr 2011 | N/A | 1,930 |
| May 2011 | N/A | 2,116 |
| Jun 2011 | N/A | 2,010 |
| Jul 2011 | N/A | 1,914 |
| Aug 2011 | N/A | 1,916 |
| Sep 2011 | N/A | 2,137 |
FY 2011 Total: 23,181
Total Abbreviated New Drug Application (ANDA) related submissions
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 3,030 |
| Nov 2010 | N/A | 2,974 |
| Dec 2010 | N/A | 3,118 |
| Jan 2011 | N/A | 3,281 |
| Feb 2011 | N/A | 3,372 |
| Mar 2011 | N/A | 3,573 |
| Apr 2011 | N/A | 3,674 |
| May 2011 | N/A | 3,869 |
| Jun 2011 | N/A | 3,626 |
| Jul 2011 | N/A | 3,531 |
| Aug 2011 | N/A | 3,576 |
| Sep 2011 | N/A | 3,416 |
FY 2011 Total: 41,040
Total Investigational New Drug (IND) related submissions
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 7,829 |
| Nov 2010 | N/A | 7,754 |
| Dec 2010 | N/A | 7,819 |
| Jan 2011 | N/A | 6,851 |
| Feb 2011 | N/A | 7,518 |
| Mar 2011 | N/A | 8,738 |
| Apr 2011 | N/A | 7,735 |
| May 2011 | N/A | 7,409 |
| Jun 2011 | N/A | 7,884 |
| Jul 2011 | N/A | 7,475 |
| Aug 2011 | N/A | 8,193 |
| Sep 2011 | N/A | 7,725 |
FY 2011 Total: 92,930
Other submissions
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 1,954 |
| Nov 2010 | N/A | 1,793 |
| Dec 2010 | N/A | 2,413 |
| Jan 2011 | N/A | 2,525 |
| Feb 2011 | N/A | 2,460 |
| Mar 2011 | N/A | 2,838 |
| Apr 2011 | N/A | 2,312 |
| May 2011 | N/A | 2,444 |
| Jun 2011 | N/A | 2,424 |
| Jul 2011 | N/A | 2,366 |
| Aug 2011 | N/A | 2,588 |
| Sep 2011 | N/A | 2,477 |
FY 2011 Total: 28,594
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.
