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Percentage of electronic ADE submissions
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 - 2013
| Time | Fiscal Year Target | Percent |
|---|---|---|
| Oct 2012 | N/A | 94 |
| Nov 2012 | N/A | 92 |
| Dec 2012 | N/A | 96 |
| Jan 2013 | N/A | 97 |
| Feb 2013 | N/A | 93 |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 94%
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 - 2013
| Time | Fiscal Year Target | Number |
|---|---|---|
| Oct 2012 | N/A | 6,510 |
| Nov 2012 | N/A | 5,873 |
| Dec 2012 | N/A | 5,670 |
| Jan 2013 | N/A | 6,068 |
| Feb 2013 | N/A | 5,594 |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 29,715
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 - 2013
| Time | Fiscal Year Target | Number |
|---|---|---|
| Oct 2012 | N/A | 425 |
| Nov 2012 | N/A | 480 |
| Dec 2012 | N/A | 225 |
| Jan 2013 | N/A | 206 |
| Feb 2013 | N/A | 420 |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 1,756
Total number of ADE reports received during the month
Fiscal Year - 2013
| Time | Fiscal Year Target | Number |
|---|---|---|
| Oct 2012 | N/A | 6,935 |
| Nov 2012 | N/A | 6,353 |
| Dec 2012 | N/A | 5,892 |
| Jan 2013 | N/A | 6,274 |
| Feb 2013 | N/A | 6,014 |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 31,468
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.
