Yale, Mayo Clinic to team up on medical regulation

New Haven, Conn.-based Yale University and Rochester, Minn.-based Mayo Clinic are establishing a Center for Excellence in Regulatory Science and Innovation to advance medical product development.

The CERSI is funded by a two-year, $6.7 million grant from the Food and Drug Administration. Its primary goals are tripartite: to make existing data from clinical trials, genomic databases and biobanks usable in regulatory decision-making; to increase analytic capability for the FDA; and to spread this knowledge to other FDA CERSIs.

"This cooperative grant creates a unique opportunity for the faculty and trainees at Yale and Mayo Clinic to use their combined research expertise to examine massive amounts of data and engage with the FDA in meaningful, data-driven change, supporting efforts to protect the public's health, and improve health care for patients," Joseph Ross,
MD, associate professor of medicine and public health at Yale and principal investigator of the award, said in a press release.

Dr. Ross will co-lead the center with Nilay Shah, PhD, associate professor of health services research at Mayo Clinic.


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