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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 June 30, 2014.

Fiscal Year - 2013

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TimeTargetPercent
Oct 2012N/A94
Nov 2012N/A92
Dec 2012N/A87
Jan 2013N/A97
Feb 2013N/A94
Mar 2013N/A96
Apr 2013N/A96
May 2013N/A97
Jun 2013N/A98
Jul 2013N/A97
Aug 2013N/A97
Sep 2013N/A97

FY 2013 Overall: 95%

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
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TimeTargetNumber
Oct 2012N/A6,265
Nov 2012N/A5,752
Dec 2012N/A5,155
Jan 2013N/A6,057
Feb 2013N/A6,647
Mar 2013N/A6,412
Apr 2013N/A8,563
May 2013N/A7,463
Jun 2013N/A7,715
Jul 2013N/A9,144
Aug 2013N/A7,100
Sep 2013N/A6,649

FY 2013 Total: 82,922

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
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TimeTargetNumber
Oct 2012N/A425
Nov 2012N/A480
Dec 2012N/A225
Jan 2013N/A206
Feb 2013N/A420
Mar 2013N/A251
Apr 2013N/A343
May 2013N/A209
Jun 2013N/A195
Jul 2013N/A281
Aug 2013N/A253
Sep 2013N/A234

FY 2013 Total: 3,522

Total number of ADE reports received during the month

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A6,690
Nov 2012N/A6,232
Dec 2012N/A5,892
Jan 2013N/A6,263
Feb 2013N/A7,067
Mar 2013N/A6,663
Apr 2013N/A8,906
May 2013N/A7,672
Jun 2013N/A7,910
Jul 2013N/A9,425
Aug 2013N/A7,353
Sep 2013N/A6,883

FY 2013 Total: 86,444

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.