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U.S. Department of Health and Human Services

About FDA

Number of manufacturer adverse event (AE) reports received in the month

Dictionary: The FDA receives hundreds of thousands of AE reports each year. The AE reports are monitored very closely to determine whether or not a serious safety signal is observed and whether a regulatory action might be necessary.


These measures has been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

Fiscal Year - 2011

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TimeTargetNumber
Oct 2010N/A56,915
Nov 2010N/A64,974
Dec 2010N/A82,822
Jan 2011N/A65,235
Feb 2011N/A58,558
Mar 2011N/A75,200
Apr 2011N/A69,325
May 2011N/A70,655
Jun 2011N/A75,374
Jul 2011N/A71,882
Aug 2011N/A77,475
Sep 2011N/A73,098

FY 2011 Total: 841,513

Percent manufacturer AE reports received electronically in the month

Dictionary: The FDA receives hundreds of thousands of AE reports each year. The AE reports are monitored very closely to determine whether or not a serious safety signal is observed and whether a regulatory action might be necessary.

Fiscal Year - 2011

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TimeTargetPercent
Oct 2010N/A81
Nov 2010N/A73
Dec 2010N/A79
Jan 2011N/A81
Feb 2011N/A80
Mar 2011N/A75
Apr 2011N/A76
May 2011N/A79
Jun 2011N/A81
Jul 2011N/A68
Aug 2011N/A82
Sep 2011N/A81

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.