• Decrease
  • Normal
  • Increase
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 - 2011

Skip graphic and jump to text data

TimeTargetNumber
Oct 2010N/A2,213
Nov 2010N/A2,448
Dec 2010N/A2,182
Jan 2011N/A2,143
Feb 2011N/A2,496
Mar 2011N/A2,633
Apr 2011N/A2,286
May 2011N/A2,161
Jun 2011N/A2,447
Jul 2011N/A2,229
Aug 2011N/A2,404
Sep 2011N/A2,442

FY 2011 Total: 28,084

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 - 2011

Skip graphic and jump to text data

TimeTargetPercent
Oct 2010N/A0
Nov 2010N/A0
Dec 2010N/A0
Jan 2011N/A0
Feb 2011N/A0
Mar 2011N/A0
Apr 2011N/A0
May 2011N/A0
Jun 2011N/A0
Jul 2011N/A24
Aug 2011N/A48
Sep 2011N/A46

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.