• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

Percent electronic-based expedited reports received in the month

FY 2011 Target: 90%

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 - 2011

Skip graphic and jump to text data

FY 2011 Target: 90%

TimeAnnual TargetPercent
Oct 2010N/A89
Nov 2010N/A89
Dec 2010N/A89
Jan 2011N/A88
Feb 2011N/A89
Mar 2011N/A90
Apr 2011N/A88
May 2011N/A89
Jun 2011N/A91
Jul 2011N/A89
Aug 2011N/A88
Sep 2011N/A91

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 - 2011

Skip graphic and jump to text data

TimeTargetNumber
Oct 2010N/A31,534
Nov 2010N/A32,639
Dec 2010N/A37,126
Jan 2011N/A30,755
Feb 2011N/A32,404
Mar 2011N/A39,279
Apr 2011N/A36,241
May 2011N/A37,015
Jun 2011N/A44,337
Jul 2011N/A35,695
Aug 2011N/A39,472
Sep 2011N/A37,575

FY 2011 Total: 434,072

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 - 2011

Skip graphic and jump to text data

TimeTargetPercent
Oct 2010N/A11
Nov 2010N/A11
Dec 2010N/A11
Jan 2011N/A12
Feb 2011N/A11
Mar 2011N/A10
Apr 2011N/A12
May 2011N/A11
Jun 2011N/A9
Jul 2011N/A11
Aug 2011N/A12
Sep 2011N/A9

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 - 2011

Skip graphic and jump to text data

TimeTargetNumber
Oct 2010N/A3,776
Nov 2010N/A4,024
Dec 2010N/A4,371
Jan 2011N/A3,998
Feb 2011N/A4,163
Mar 2011N/A4,419
Apr 2011N/A4,738
May 2011N/A4,732
Jun 2011N/A4,466
Jul 2011N/A4,360
Aug 2011N/A5,618
Sep 2011N/A3,583

FY 2011 Total: 52,248

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.