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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 December 31, 2014.

Fiscal Year - 2015

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TimeTargetPercent
Oct - Dec 2014N/A97
Jan - Mar 2015N/ATBD
Apr - Jun 2015N/ATBD
Jul - Sept 2015N/ATBD

FY 2015 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 - 2015
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TimeTargetNumber
Oct - Dec 2014N/A21,255
Jan - Mar 2015N/ATBD
Apr - Jun 2015N/ATBD
Jul - Sept 2015N/ATBD

FY 2015 YTD: 21,255

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 - 2015
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TimeTargetNumber
Oct - Dec 2014N/A578
Jan - Mar 2015N/ATBD
Apr - Jun 2015N/ATBD
Jul - Sept 2015N/ATBD

FY 2015 YTD: 578

Total number of ADE reports received during the month

Fiscal Year - 2015
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TimeTargetNumber
Oct - Dec 2014N/A21,833
Jan - Mar 2015N/ATBD
Apr - Jun 2015N/ATBD
Jul - Sept 2015N/ATBD

FY 2015 YTD: 21,833

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.