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.

• FY 2011
• FY 2012
• All

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.

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.

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.