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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 - 2014

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TimeTargetPercent
Oct 2013N/A98
Nov 2013N/A97
Dec 2013N/A99
Jan 2014N/A98
Feb 2014N/A98
Mar 2014N/A93
Apr 2014N/A96
May 2014N/A97
Jun 2014N/A96
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 97%

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 - 2014
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TimeTargetNumber
Oct 2013N/A8,517
Nov 2013N/A6,525
Dec 2013N/A5,820
Jan 2014N/A6,085
Feb 2014N/A5,015
Mar 2014N/A5,589
Apr 2014N/A4,891
May 2014N/A7,807
Jun 2014N/A8,349
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 58,598

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 - 2014
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TimeTargetNumber
Oct 2013N/A182
Nov 2013N/A171
Dec 2013N/A88
Jan 2014N/A143
Feb 2014N/A118
Mar 2014N/A428
Apr 2014N/A201
May 2014N/A254
Jun 2014N/A339
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 1,924

Total number of ADE reports received during the month

Fiscal Year - 2014
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TimeTargetNumber
Oct 2013N/A8,699
Nov 2013N/A6,696
Dec 2013N/A5,908
Jan 2014N/A6,228
Feb 2014N/A5,133
Mar 2014N/A6,017
Apr 2014N/A5,092
May 2014N/A8,061
Jun 2014N/A8,688
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 60,522

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.