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 (JHU). 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. The UCSF-Stanford CERSI will be three years long while JHU will be two years long.
Briefing Status: ON TRACK
Prior Briefing Status: ON TRACK
Milestone Description | Milestone Date | Milestone Status | Milestone 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 (12/31/2014) |
Completed | 2/27/2015 |
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 (3/31/2015) |
Completed | 3/31/2015 |
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 (6/30/2015) |
Completed | 6/29/2015 |
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 (9/30/2015) |
Completed | 10/15/2015 |
I. Evaluate the second year renewal request and approve the continuation of the funding with the FDA steering committee |
7/30/2015 (10/31/2015) |
Completed | 11/30/2015 |
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 (12/31/2015) |
Completed | 12/15/2015 |
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 (3/31/2016) |
Completed | 2/20/2016 |
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 (6/30/2016) |
Completed | 5/30/2016 |
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 (9/30/2016) |
Completed | 7/30/2016 |
N. Evaluate the third year renewal request and approve the continuation of the funding with the FDA steering committee (UCSF-Stanford only) |
3/31/2016 (10/25/2016) |
Completed | 10/30/2016 |
O. 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 (UCSF-Stanford only) |
12/31/2016 |
Completed | 12/30/2016 |
P. Review the final report for JHU |
12/31/2016 |
Completed | 12/30/2016 |
Q. 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 (UCSF-Stanford only) |
3/31/2017 |
Completed | 3/21/2017 |
R. 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 (UCSF-Stanford only) |
6/30/2017 |
Completed | 6/16/2017 |
S. 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 (UCSF-Stanford only) |
9/30/2017 |
Completed | 8/30/2017 |
T. Review the mid-year report from JHU, UCSF, YaleMayo, and UMD |
2/28/2018 |
Completed | |
U. Review the end of year report from JHU, UCSF, YaleMayo and UMD |
8/30/2018 |
Completed |
Foot Notes
- The dates in italics are modified milestone due dates that have been updated due to real-time delays.
Key Projects Legend
Milestone Status | Definition |
---|---|
Not Yet Started | Work for specific milestone has not yet been started. |
Completed | Milestone and/or overall project is completed. |
On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |