“The Food and Drug Administration plans to create a new office to improve the review of new medicines — one that will develop a standardized approach to using personalized medicine, digital data, and patients’ own reports, according to Commissioner Scott Gottlieb.”
Gottlieb will outline the plan for the new 52-person group, called the Office of Drug Evaluation Science (ODES), as part of a talk at the annual J.P. Morgan Healthcare Conference…
“Another important mission for the new office will be understanding how to turn what patients tell doctors into structured data…” Read the full article here.
Source: FDA plans to create a new office to leverage cutting-edge science – By Matthew Herper, January 7, 2019. STAT News.