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U.S. Department of Health and Human Services

About FDA

Advance MCM Regulatory Science Programs

Description: Support MCM development and evaluation by establishing regulatory science programs for MCM products, based on both intra- and extramural, collaborative research programs.

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Launch MCM regulatory science program by establishing steering committee/governance board


Completed 12/23/2010

2. Initiate intramural component of MCM regulatory science program


Completed 1/31/2011

3. Co-sponsor with Institute of Medicine (IOM) a public workshop to obtain external stakeholder input on MCM regulatory science needs


Completed 3/29-30/2011 [1]

4. Continue to assess regulatory science needs through formal request for information (RFI)


Completed 8/19/2011

5. Initiate extramural component of the regulatory science program


Completed 8/19/2011

6. Establish an MOU with the DoD’s Defense Advanced Research Projects Agency (DARPA) to collaborate on regulatory science research in support of innovative regulatory tools, such as biomimetic models, that can be used in development and approval of MCMs


Completed 2/7/2011


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.