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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 February 28, 2013.
Fiscal Year - 2012
Fiscal Year Target: 5%
| Time | Target | Percent |
|---|---|---|
| Oct 2011 | N/A | 61 |
| Nov 2011 | N/A | 65 |
| Dec 2011 | N/A | 47 |
| Jan 2012 | N/A | 68 |
| Feb 2012 | N/A | 77 |
| Mar 2012 | N/A | 68 |
| Apr 2012 | N/A | 82 |
| May 2012 | N/A | 82 |
| Jun 2012 | N/A | 64 |
| Jul 2012 | N/A | 80 |
| Aug 2012 | N/A | 96 |
| Sep 2012 | N/A | 81 |
FY 2012 Overall: 75%
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 - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 3,065 |
| Nov 2011 | N/A | 2,595 |
| Dec 2011 | N/A | 1,477 |
| Jan 2012 | N/A | 3,492 |
| Feb 2012 | N/A | 3,806 |
| Mar 2012 | N/A | 3,506 |
| Apr 2012 | N/A | 4,864 |
| May 2012 | N/A | 5,399 |
| Jun 2012 | N/A | 5,969 |
| Jul 2012 | N/A | 6,496 |
| Aug 2012 | N/A | 7,739 |
| Sep 2012 | N/A | 6,399 |
FY 2012 Total: 54,807
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 - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 1,948 |
| Nov 2011 | N/A | 1,397 |
| Dec 2011 | N/A | 1,686 |
| Jan 2012 | N/A | 1,634 |
| Feb 2012 | N/A | 1,139 |
| Mar 2012 | N/A | 1,643 |
| Apr 2012 | N/A | 1,080 |
| May 2012 | N/A | 1,215 |
| Jun 2012 | N/A | 3,416 |
| Jul 2012 | N/A | 1,583 |
| Aug 2012 | N/A | 331 |
| Sep 2012 | N/A | 1,527 |
FY 2012 Total: 18,599
Total number of ADE reports received during the month
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 5,013 |
| Nov 2011 | N/A | 3,992 |
| Dec 2011 | N/A | 3,163 |
| Jan 2012 | N/A | 5,126 |
| Feb 2012 | N/A | 4,945 |
| Mar 2012 | N/A | 5,149 |
| Apr 2012 | N/A | 5,944 |
| May 2012 | N/A | 6,614 |
| Jun 2012 | N/A | 9,385 |
| Jul 2012 | N/A | 8,079 |
| Aug 2012 | N/A | 8,070 |
| Sep 2012 | N/A | 7,926 |
FY 2012 Total: 73,406
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.
