Enhance Review and Approval Processes

Enhance Review and Approval ProcessesEnhance 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.

COMPLETED

ON TRACK

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

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

http://www.fda.gov/AboutFDA/Transparency/track/ucm237964.htmFDA-TRACK Medical Countermeasures Initiative (MCMi) Dashboardhttp://www.fda.gov/EmergencyPreparedness/MedicalCountermeasures/default.htmMedical Countermeasures Initiative (MCMi)

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