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U.S. Department of Health and Human Services

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Percentage of Reported Serious Adverse Events from the Adverse Reporting System (AERS) that were reviewed within 2 business days by a medical officer during the month (1)

Dictionary: With the enactment of the Food and Drug Administration Amendments Act of 2007, OBE was given expanded authority to develop the capacity, methods, and tools to ensure the safety of biological products over the life cycle (from development to use). A significant part of OBE oversight is directed to ensuring the safety of marketed biological products. OBE medical officers review one hundred percent of reported SAE in one or two business days. The medical reviews of reported Serious Adverse Events (SAE) are filed with the Vaccine Adverse Event Reporting System (VAERS) and with the Adverse Event Reporting System (AERS). The VAERS is a national surveillance program designed to detect possible adverse events associated with vaccines. The AERS is a computerized information database that FDA uses to monitor new adverse events and medication errors. This program measure documents the monthly workload of OBE’s review of VAERS and AERS reports. Number of Serious Adverse Events received each month includes SAEs from VAERS and AERS

Information is current as of September 30, 2012

Fiscal Year - 2010

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TimeTargetPercentage
Oct 2009N/AN/A
Nov 2009N/AN/A
Dec 2009N/AN/A
Jan 2010N/AN/A
Feb 2010N/AN/A
Mar 2010N/AN/A
Apr 2010N/AN/A
May 2010N/AN/A
Jun 2010N/AN/A
Jul 2010N/AN/A
Aug 2010N/AN/A
Sep 2010N/AN/A

Footnotes

  • (1) Tracking against these measures did not start until January 2011.

Number of Serious Adverse Events received each month from the Adverse Event Reporting System (AERS) (1)

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/AN/A
Nov 2009N/AN/A
Dec 2009N/AN/A
Jan 2010N/AN/A
Feb 2010N/AN/A
Mar 2010N/AN/A
Apr 2010N/AN/A
May 2010N/AN/A
Jun 2010N/AN/A
Jul 2010N/AN/A
Aug 2010N/AN/A
Sep 2010N/AN/A

Footnotes

  • (1) Tracking against these measures did not start until January 2011.

Number of Reported Serious Adverse Events from the Adverse Event Reporting System (AERS) that were reviewed within 2 business days by a medical officer during the month (1)

Fiscal Year - 2010
Skip graphic and jump to text data.

TimeTargetNumber
Jan 2010N/A190
Feb 2010N/A171
Mar 2010N/A189
Apr 2010N/A201
May 2010N/A227
Jun 2010N/A208
Jul 2010N/A222
Aug 2010N/A214
Sep 2010N/A259

FY 2010 9-month Total: 978

Footnotes

  • (1) Tracking against these measures did not start until January 2010

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.