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U.S. Department of Health and Human Services

About FDA

ADE Reports System Project

Description: Develop capability to receive ADE reports electronically and work with stakeholders to educate and encourage electronic submission of ADE reports. Due to the continuing increase in the number of ADEs submitted annually (approximately 45,000 reports), the subsequent increasing ADE backlog, the growing medical complexity of approved products, and the limits of the current manual entry system, the pharmacovigilance program is unable to appropriately review and evaluate the data to provide real-time surveillance to proactively identify safety signals (e.g., data mining) and respond to hazards that threaten animal and public health. Implementation of electronic data submission is an extremely valuable capability that will allow electronic receipt of ADEs to prepopulate PV Works, the CVM database, helping CVM respond to this challenge. (1)

Accomplishment: The ADE electronic reporting system implemented in May 2010 was upgraded in June 2013. Outreach efforts continued with workshops, meetings and one-on-one interaction with stakeholders. At the end of FY13, approximately 95% of veterinary adverse event reports were received electronically and these public milestones have been completed successfully.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Draft FR notice of revised forms for electronic reporting from industry and send to OMB

3/31/2010

Completed 3/10/2010

2. Ensure CVM Gateway-to-Gateway interface is capable of receiving electronic reports

4/16/2010

Completed 5/24/2010

3. Create CVM Update on FDA website to alert sponsors of electronic reporting capability (especially those who may not use PV Works)

6/1/2010

Completed 5/24/2010

4. Develop Outreach program encouraging electronic submission of ADE reports by sponsors

7/10/2010

Completed 5/24/2010

Footnotes

  • (1) Milestones to be completed in FY 2013 are under development.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

ADE

Adverse Drug Event or Experience

FR

Federal Register

OMB

Office of Management and Budget

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.