The reorganization had its origins in the Reagan-Udall Foundation report, which was released less than two years ago. The report focused on ways to clarify the mission of the human food program and achieve more urgency in preventing foodborne illnesses.

The oncology quality, characterization, and assessment of real-world data (Oncology QCARD) Initiative was formed to develop a set of minimum study design and data elements needed to evaluate the fitness of the real-world data (RWD) source(s) proposed in an initial study concept as part of early interaction with scientific reviewers.