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U.S. Department of Health and Human Services

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Percent electronic-based expedited reports received in the month

Dictionary: Drug manufacturers are required to submit to FDA reports of adverse events they receive related to their products. These reports provide crucial information to help enable CDER to monitor the post-market safety of drug products in use. Currently, manufacturers may submit these reports to CDER by mail, fax, or electronically through CDER’s MedWatch portal. As electronic reporting streamlines CDER processes, saves time and money, and ensures quicker reporting, CDER is committed to increasing the proportion of reports submitted electronically. FDA is currently developing an improved web-interface reporting system to be called MedWatch Plus. The MedWatch Plus portal will include a rational questionnaire which will help facilitate improved communication, ease of reporting, and enable more complete and higher quality reporting. This timelier and higher quality reporting will positively affect public heath by enabling improved scientific analysis of adverse event reporting and more timely and accurate detection of safety signals.


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 - 2012

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TimeTargetPercent
Oct 2011N/A91
Nov 2011N/A91
Dec 2011N/A91
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

Number of electronic-based expedited reports received in the month

Dictionary: Drug manufacturers are required to submit to FDA reports of adverse events they receive related to their products. These reports provide crucial information to help enable CDER to monitor the post-market safety of drug products in use. Currently, manufacturers may submit these reports to CDER by mail, fax, or electronically through CDER’s MedWatch portal. As electronic reporting streamlines CDER processes, saves time and money, and ensures quicker reporting, CDER is committed to increasing the proportion of reports submitted electronically. FDA is currently developing an improved web-interface reporting system to be called MedWatch Plus. The MedWatch Plus portal will include a rational questionnaire which will help facilitate improved communication, ease of reporting, and enable more complete and higher quality reporting. This timelier and higher quality reporting will positively affect public heath by enabling improved scientific analysis of adverse event reporting and more timely and accurate detection of safety signals.

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A36,992
Nov 2011N/A38,850
Dec 2011N/A39,260
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 115,102

Percent paper-based expedited reports received in the month

Dictionary: Drug manufacturers are required to submit to FDA reports of adverse events they receive related to their products. These reports provide crucial information to help enable CDER to monitor the post-market safety of drug products in use. Currently, manufacturers may submit these reports to CDER by mail, fax, or electronically through CDER’s MedWatch portal. As electronic reporting streamlines CDER processes, saves time and money, and ensures quicker reporting, CDER is committed to increasing the proportion of reports submitted electronically. FDA is currently developing an improved web-interface reporting system to be called MedWatch Plus. The MedWatch Plus portal will include a rational questionnaire which will help facilitate improved communication, ease of reporting, and enable more complete and higher quality reporting. This timelier and higher quality reporting will positively affect public heath by enabling improved scientific analysis of adverse event reporting and more timely and accurate detection of safety signals.

Fiscal Year - 2012

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TimeTargetPercent
Oct 2011N/A9
Nov 2011N/A9
Dec 2011N/A9
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

Number of paper-based expedited reports received in the month

Dictionary: Drug manufacturers are required to submit to FDA reports of adverse events they receive related to their products. These reports provide crucial information to help enable CDER to monitor the post-market safety of drug products in use. Currently, manufacturers may submit these reports to CDER by mail, fax, or electronically through CDER’s MedWatch portal. As electronic reporting streamlines CDER processes, saves time and money, and ensures quicker reporting, CDER is committed to increasing the proportion of reports submitted electronically. FDA is currently developing an improved web-interface reporting system to be called MedWatch Plus. The MedWatch Plus portal will include a rational questionnaire which will help facilitate improved communication, ease of reporting, and enable more complete and higher quality reporting. This timelier and higher quality reporting will positively affect public heath by enabling improved scientific analysis of adverse event reporting and more timely and accurate detection of safety signals.

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A3,545
Nov 2011N/A3,977
Dec 2011N/A4,027
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 11,549

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.