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U.S. Department of Health and Human Services

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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 December 31, 2013.

Fiscal Year - 2012

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Fiscal Year Target: 5%

TimeTargetPercent
Oct 2011N/A61
Nov 2011N/A65
Dec 2011N/A47
Jan 2012N/A68
Feb 2012N/A77
Mar 2012N/A68
Apr 2012N/A82
May 2012N/A82
Jun 2012N/A64
Jul 2012N/A80
Aug 2012N/A96
Sep 2012N/A81

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
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TimeTargetNumber
Oct 2011N/A3,065
Nov 2011N/A2,595
Dec 2011N/A1,477
Jan 2012N/A3,492
Feb 2012N/A3,806
Mar 2012N/A3,506
Apr 2012N/A4,864
May 2012N/A5,399
Jun 2012N/A5,969
Jul 2012N/A6,496
Aug 2012N/A7,739
Sep 2012N/A6,399

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
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TimeTargetNumber
Oct 2011N/A1,948
Nov 2011N/A1,397
Dec 2011N/A1,686
Jan 2012N/A1,634
Feb 2012N/A1,139
Mar 2012N/A1,643
Apr 2012N/A1,080
May 2012N/A1,215
Jun 2012N/A3,416
Jul 2012N/A1,583
Aug 2012N/A331
Sep 2012N/A1,527

FY 2012 Total: 18,599

Total number of ADE reports received during the month

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A5,013
Nov 2011N/A3,992
Dec 2011N/A3,163
Jan 2012N/A5,126
Feb 2012N/A4,945
Mar 2012N/A5,149
Apr 2012N/A5,944
May 2012N/A6,614
Jun 2012N/A9,385
Jul 2012N/A8,079
Aug 2012N/A8,070
Sep 2012N/A7,926

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.