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U.S. Department of Health and Human Services

About FDA

Assessment of histopathology practices in biomarker qualification

Description: This project will adopt modern tissue imaging methods to the quantification of drug-induced injury to specific organs in appropriate animal models (e.g. incipient pancreas injury in Sprague-Dawley rats exposed to low doses of anti-diabetic drugs).

This key project has been retired as CDER has created new measures and key projects 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.

Briefing Status: ON HOLD

Prior Briefing Status: ON HOLD

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Develop concept paper


Completed 3/31/2010

2. Finalize research plan


Completed 4/15/2010

3. Submit protocol


Completed 4/22/2010

4. Initiate study


Completed 5/1/2010

5. Conduct interim analysis


Completed 7/15/2010

6. Complete study (1)

9/30/2010 (4/30/2012)

Not Yet Started

7. Release study report (1)

12/31/2010 (7/31/2012)

Not Yet Started


  • (1) The dates in italics under the milestone due dates are revised milestone due dates which have been updated.

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.


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.