Intersections of technological and regulatory zones in regenerative medicine

Abstract

This chapter situates contemporary debates over regenerative medicine governance within a broader framework, taking intersections with economic, political, and other kinds of technological zones into account. With the inherent complexities of regenerative medicine products, the advent of techniques such as gene editing and tissue organoids, and pragmatic problems of scaling-up cell manufacturing, conventional ways of thinking about and producing evidence are challenged. At the same time, the push to speed product approvals endures, but now in political and economic environments that include differing attitudes toward risk and patients’ roles in decision-making. The chapter highlights how crossing technological and political zones, data-driven approaches plus a return to observational data in particular are being incorporated into US regulatory law and product review.