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U.S. Department of Health and Human Services

About FDA

Centers of Excellence in Regulatory Science and Innovation (CERSI)

Description: Two CERSIs have been established in collaboration with Georgetown University and the University of Maryland to foster an innovative and thematically coherent approach to advance the field of Regulatory Science toward more effective and efficient product development and evaluation. CERSI efforts focus on promoting innovation in support of the development and evaluation of safe and effective products through training, applied collaborative science, professional development, and scientific exchanges. Internal FDA steering committees composed of scientific experts from multiple Centers at FDA and the Office of the Commissioner meet quarterly to guide the CERSIs and ensure their work is furthering the FDA mission by addressing the priority areas found in Advancing Regulatory Science at FDA - A Strategic Plan.

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Hold Kick Off Meeting


Completed 10/1/2011

B. Schedule CERSI Presentations with the Science Board to the FDA


Completed 3/30/2012

C. Review CERSI Proposals for Year 2


Completed 6/30/2012

D. Award CERSI Proposals for Year 2


Completed 9/30/2012

E. Review Year 2 Quarter 1 milestones


Completed 1/18/2013

F. Review Year 2 Quarter 2 milestones


Completed 3/21/2013

G. Review Year 2 Quarter 3 milestones


Completed 6/28/2013

H. Review Year 2 Quarter 4 milestones


Not Yet Started

I. Review year 2 regulatory science education exchange


Not Yet Started

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.