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U.S. Department of Health and Human Services

About FDA

Centers of Excellence in Regulatory Science and Innovation (CERSI) Established in 2014

Description: Two new CERSIs have been established between the FDA and teams of leading scientists at the University of California at San Francisco (UCSF) in a joint effort with Stanford University, and Johns Hopkins University. Both partners received FDA funding through a competitive application process to establish CERSIs that will promote cross-disciplinary regulatory science training, scientific exchanges, and leading-edge research focused on FDA science priority areas. The UCSF-Stanford CERSI will bring West Coast representation to the CERSI network and enable the FDA to access UCSF’s powerhouse in quantitative sciences and in drug development whereas the Johns Hopkins CERSI will focus on three core FDA strategic priorities: clinical evaluations, social and behavioral science, and food safety. Collaborating with our academic partners is crucial to our ability to expand the FDA’s scientific foundation and infrastructure in order to deliver on the promises of using 21st century science and technology to fulfill our regulatory mission.

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Post RFA

5/15/2013

Completed 5/15/2013

B. Collect proposals

7/8/2013

Completed 7/8/2013

C. Review proposals

10/30/2013

Completed 10/30/2013

D. Notify the selection

4/1/2014

Completed 4/7/2014

E. Review the year 1 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

7/31/2014

Not Yet Started

F. Review the year 1 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

10/31/2014

Not Yet Started

G. Review the year 1 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

1/30/2015

Not Yet Started

H. Review the year 1 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

4/30/2015

Not Yet Started

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

7/30/2015

Not Yet Started

J. Review the 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

10/16/2015

Not Yet Started

K. Review the 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

1/19/2016

Not Yet Started

L. Review the 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

4/26/2016

Not Yet Started

M. Review the 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

7/18/2016

Not Yet Started

N. Review the final report

10/25/2016

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.