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U.S. Department of Health and Human Services

About FDA

Number of Adverse Events (AE) reported for drugs/biological products (15-day manufacture reports)

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.

Information is current as of March 31, 2014.

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/AN/A
Nov 2011N/AN/A
Dec 2011N/AN/A
Jan 2012N/AN/A
Feb 2012N/AN/A
Mar 2012N/AN/A
Apr 2012N/AN/A
May 2012N/AN/A
Jun 2012N/AN/A
Jul 2012N/A40,308
Aug 2012N/A42,167
Sep 2012N/A39,404

FY 2012 3 month Total: 121,879

Footnotes

  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.

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.