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 Description | Milestone Date | Milestone Status | Milestone 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 Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - 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.
