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U.S. Department of Health and Human Services

About FDA

Enhance Review and Approval Processes

Description: Enhance development, evaluation, approval, and surveillance processes for high-priority MCMs and platform technologies; create Action Teams to analyze processes, identify gaps and hurdles, and propose recommendations for improvement.

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Develop tools for tracking MCM regulatory product status

1/15/2011

Completed 1/31/2011

2. Establish in vitro device (IVD) Action Team to focus on highest priority MCMs

6/30/2011

Completed 6/1/2011

3. Hold workshop on development and evaluation of next-generation smallpox vaccines

9/30/2011

Completed 9/16/2011

4. Establish acute radiation syndrome Action Team

10/30/2011

Completed 7/5/2011

5. Establish Action Team for trauma

12/30/2011

Completed 11/2/2011

6. Draft MOU to facilitate information sharing among Enterprise members on Action Teams

12/30/2011

Completed 10/6/2011 [1]

7. Hold FDA (CDRH) public workshop on gaps and regulatory challenges in developing multiplex IVD platforms

12/31/2011

Completed 10/13/2011

8. Hold workshop on MCMs for pediatric populations (winter 2012)

12/30/2012

Completed 2/15-16/2012

9. Finalize MOU with Assistant Secretary for Preparedness and Response (ASPR)/Biomedical Advanced Research and Development Authority (BARDA) to facilitate coordination and collaborative efforts related to the development and availability of MCMs

4/30/2012

Completed 5/23/2012

Footnotes

  • [1] Final MOU negotiations with Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) partners are underway.
  • Additional milestones are currently 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

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.