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U.S. Department of Health and Human Services

About FDA

Review of Adverse Event Reports

Description: OCTGT will collect data on the completion of amendment assignments for adverse event reports for products under IND for possible future application. Consistent and timely review of adverse event reports allows FDA to trend potential safety risks associated with certain product classes and at risk patient populations. Collection of adverse event data will provide for better patient safety, while allowing novel cell and gene therapy products to proceed through product development and into clinical studies.

Accomplishment: The Office of Cellular, Tissue, and Gene Therapies (OCTGT) collected data to determine whether it is feasible to develop a measure for completion of amendment assignments for initial serious adverse event reports for products under IND. OCTGT has determined that a measure will be feasible. Consistent and timely review of adverse event reports will allow OCTGT FDA to trend potential safety risks associated with certain product classes and at risk patient populations. Collection of adverse event data will provide for better patient safety, while allowing novel cell and gene therapy products to proceed through product development and into clinical studies.

Briefing Status: Completed

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Collect data for the quarter, review the complete data set, and observe for trends

1/31/2013

Completed 1/4/2013

B. Collect data for the quarter, review the complete data set, and observe for trends

4/30/2013

Completed 4/5/2013

C. Collect data for the quarter, review the complete data set, and observe for trends

7/31/2013

Completed 7/1/2013

D. Collect data for the quarter, review the complete data set, and observe for trends

10/31/2013

Completed 9/30/2013

E. Identify possible application of the data and determine next steps

1/31/2014

Completed 12/31/2013

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

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.