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U.S. Department of Health and Human Services

About FDA

Number of direct-to-FDA 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/A2,600
Nov 2009N/A2,715
Dec 2009N/A2,332
Jan 2010N/A2,510
Feb 2010N/A2,680
Mar 2010N/A2,987
Apr 2010N/A2,503
May 2010N/A2,593
Jun 2010N/A2,092
Jul 2010N/A2,229
Aug 2010N/A2,245
Sep 2010N/A2,077

Percent direct-to-FDA 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/A0
Nov 2009N/A0
Dec 2009N/A0
Jan 2010N/A0
Feb 2010N/A0
Mar 2010N/A0
Apr 2010N/A0
May 2010N/A0
Jun 2010N/A0
Jul 2010N/A0
Aug 2010N/A0
Sep 2010N/A0

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.