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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 March 31, 2014.

Fiscal Year - 2011

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Fiscal Year Target: 5%

TimeTargetPercent
Oct 2010N/A0
Nov 2010N/A0
Dec 2010N/A0
Jan 2011N/A0
Feb 2011N/A0
Mar 2011N/A5
Apr 2011N/A15
May 2011N/A8
Jun 2011N/A9
Jul 2011N/A7
Aug 2011N/A40
Sept 2011N/A59

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
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TimeTargetNumber
Oct 2010N/A0
Nov 2010N/A0
Dec 2010N/A0
Jan 2011N/A0
Feb 2011N/A0
Mar 2011N/A242
Apr 2011N/A854
May 2011N/A437
Jun 2011N/A492
Jul 2011N/A341
Aug 2011N/A2,160
Sept 2011N/A3,284

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
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TimeTargetNumber
Oct 2010N/A3,752
Nov 2010N/A3,406
Dec 2010N/A4,129
Jan 2011N/A2,822
Feb 2011N/A2,528
Mar 2011N/A4,941
Apr 2011N/A4,780
May 2011N/A5,111
Jun 2011N/A5,062
Jul 2011N/A4,443
Aug 2011N/A3,263
Sept 2011N/A2,311

FY 2011 Total: 46,548

Total number of ADE reports received during the month

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A3,752
Nov 2010N/A3,406
Dec 2010N/A4,129
Jan 2011N/A2,822
Feb 2011N/A2,528
Mar 2011N/A5,183
Apr 2011N/A5,634
May 2011N/A5,548
Jun 2011N/A5,554
Jul 2011N/A4,784
Aug 2011N/A5,423
Sept 2011N/A5,595

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.