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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

• FY 2010
• FY 2011
• FY 2012
• All

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

Time	Target	Number
Oct 2009	N/A	N/A
Nov 2009	N/A	N/A
Dec 2009	N/A	N/A
Jan 2010	N/A	N/A
Feb 2010	N/A	N/A
Mar 2010	N/A	N/A
Apr 2010	N/A	N/A
May 2010	N/A	N/A
Jun 2010	N/A	N/A
Jul 2010	N/A	N/A
Aug 2010	N/A	N/A
Sep 2010	N/A	N/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

Time	Target	Number
Jan 2010	N/A	190
Feb 2010	N/A	171
Mar 2010	N/A	189
Apr 2010	N/A	201
May 2010	N/A	227
Jun 2010	N/A	208
Jul 2010	N/A	222
Aug 2010	N/A	214
Sep 2010	N/A	259

FY 2010 9-month Total: 978

Footnotes

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