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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 (GU) and the University of Maryland (UMD) (see links below) 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 (see link below).

Accomplishment: a) Three master level regulatory science programs are currently running at the two CERSI sites, b) CERSI scientific lectures and workshops have been completed on time and more in schedule throughout FY14, c) All research programs are in collaboration with and overseen by the FDA Centers, d) The UMD CERSI hosted 10 workshops with 877 participants and the GU CERSI hosted 26 worshops with 129 participants from October 1, 2013 to May 30, 2014 (these data are also captured in the Office of Scientific Professional Development (OSPD) Training and Continuing Education Measures).

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Hold Kick Off Meeting

10/1/2011

Completed 10/1/2011

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

3/30/2012

Completed 3/30/2012

C. Review CERSI Proposals for Year 2

6/30/2012

Completed 6/30/2012

D. Award CERSI Proposals for Year 2

9/30/2012

Completed 9/30/2012

E. Review Year 2 Quarter 1 progress report and milestones, and monitor their progress through the FDA steering committee meeting with the CERSI principal investigators and the FDA staff

12/31/2012

Completed 1/18/2013

F. Review Year 2 Quarter 2 progress report and milestones, and monitor their progress through the FDA steering committee meeting with the CERSI principal investigators and the FDA staff

3/31/2013

Completed 3/21/2013

G. Review Year 2 Quarter 3 progress report and milestones, and monitor their progress through the FDA steering committee meeting with the CERSI principal investigators and the FDA staff

6/30/2013

Completed 6/28/2013

H. Review Year 2 Quarter 4 progress report and milestones, and monitor their progress through the FDA steering committee meeting with the CERSI principal investigators and the FDA staff

9/30/2013

Completed 9/30/2013

I. Evaluate the third year renewal request and approve the continuation of the funding with the FDA steering committee

9/30/2013

Completed 9/6/2013

J. Review year 3 Quarter 1 progress report and milestones, and monitor their progress through the FDA steering committee meeting with the CERSI principal investigators and the FDA staff

12/18/2013

Completed 12/18/2013

K. Review year 3 Quarter 2 progress report and milestones, and monitor their progress through the FDA steering committee meeting with the CERSI principal investigators and the FDA staff

3/19/2014

Completed 3/19/2014

L. Review year 3 Quarter 3 progress report and milestones, and monitor their progress through the FDA steering committee meeting with the CERSI principal investigators and the FDA staff

6/26/2014

Completed 6/10/2014

M. Review year 3 Quarter 4 progress report and milestones, and monitor their progress through the FDA steering committee meeting with the CERSI principal investigators and the FDA staff

9/18/2014

Not Yet Started

N. Review the final report

1/31/2015

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.

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.