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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 - 2011

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TimeTargetPercentage
Jan 2011N/A100
Feb 2011N/A100
Mar 2011N/A100
Apr 2011N/A100
May 2011N/A100
Jun 2011N/A100
Jul 2011N/A100
Aug 2011N/A100
Sep 2011N/A100

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 - 2011
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TimeTargetNumber
Jan 2011N/A190
Feb 2011N/A210
Mar 2011N/A316
Apr 2011N/A237
May 2011N/A243
Jun 2011N/A296
Jul 2011N/A288
Aug 2011N/A397
Sep 2011N/A341

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 - 2011
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2010N/A261
Nov 2010N/A220
Dec 2010N/A212
Jan 2011N/A190
Feb 2011N/A210
Mar 2011N/A316
Apr 2011N/A237
May 2011N/A243
Jun 2011N/A296
Jul 2011N/A288
Aug 2011N/A397
Sep 2011N/A341

FY 2011 Total: 3,211

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.