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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 - 2010

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TimeTargetNumber
Oct 2009N/A43,365
Nov 2009N/A55,704
Dec 2009N/A66,559
Jan 2010N/A52,107
Feb 2010N/A48,712
Mar 2010N/A57,008
Apr 2010N/A54,236
May 2010N/A49,658
Jun 2010N/A56,826
Jul 2010N/A85,479
Aug 2010N/A70,455
Sep 2010N/A67,208

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 - 2010

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TimeTargetPercent
Oct 2009N/A72
Nov 2009N/A59
Dec 2009N/A71
Jan 2010N/A61
Feb 2010N/A73
Mar 2010N/A75
Apr 2010N/A64
May 2010N/A71
Jun 2010N/A79
Jul 2010N/A85
Aug 2010N/A79
Sep 2010N/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.