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Percentage of electronic ADE submissions
Fiscal Year Target: 5%
Dictionary: The difference of the electronic ADE submissions versus the paper ADE submissions each month.
Information is current as of November 30, 2012.
Fiscal Year - 2011
Fiscal Year Target: 5%
| Time | Target | Percent |
|---|---|---|
| Oct 2010 | N/A | 0 |
| Nov 2010 | N/A | 0 |
| Dec 2010 | N/A | 0 |
| Jan 2011 | N/A | 0 |
| Feb 2011 | N/A | 0 |
| Mar 2011 | N/A | 5 |
| Apr 2011 | N/A | 15 |
| May 2011 | N/A | 8 |
| Jun 2011 | N/A | 9 |
| Jul 2011 | N/A | 7 |
| Aug 2011 | N/A | 40 |
| Sept 2011 | N/A | 59 |
FY 2011 Overall: 14%
Number of electronic ADE submissions received during the month
Electronic submissions submitted through the Safety Portal or the CVM Electronic Submissions Gateway and imported into the PVWorks database.
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 0 |
| Nov 2010 | N/A | 0 |
| Dec 2010 | N/A | 0 |
| Jan 2011 | N/A | 0 |
| Feb 2011 | N/A | 0 |
| Mar 2011 | N/A | 242 |
| Apr 2011 | N/A | 854 |
| May 2011 | N/A | 437 |
| Jun 2011 | N/A | 492 |
| Jul 2011 | N/A | 341 |
| Aug 2011 | N/A | 2,160 |
| Sept 2011 | N/A | 3,284 |
FY 2011 Total: 7,810
Number of paper ADE submissions received during the month
Paper submissions are mandatory adverse event reports from industry that are submitted directly to the Document Control Unit in CVM.
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 3,752 |
| Nov 2010 | N/A | 3,406 |
| Dec 2010 | N/A | 4,129 |
| Jan 2011 | N/A | 2,822 |
| Feb 2011 | N/A | 2,528 |
| Mar 2011 | N/A | 4,941 |
| Apr 2011 | N/A | 4,780 |
| May 2011 | N/A | 5,111 |
| Jun 2011 | N/A | 5,062 |
| Jul 2011 | N/A | 4,443 |
| Aug 2011 | N/A | 3,263 |
| Sept 2011 | N/A | 2,311 |
FY 2011 Total: 46,548
Total number of ADE reports received during the month
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 3,752 |
| Nov 2010 | N/A | 3,406 |
| Dec 2010 | N/A | 4,129 |
| Jan 2011 | N/A | 2,822 |
| Feb 2011 | N/A | 2,528 |
| Mar 2011 | N/A | 5,183 |
| Apr 2011 | N/A | 5,634 |
| May 2011 | N/A | 5,548 |
| Jun 2011 | N/A | 5,554 |
| Jul 2011 | N/A | 4,784 |
| Aug 2011 | N/A | 5,423 |
| Sept 2011 | N/A | 5,595 |
FY 2011 Total: 54,358
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.
