Reimagining FDA: Creating a 21st century regulatory agency

No institution plays a greater role in protecting the health of people in the U.S., or in sustaining the global life sciences ecosystem, than FDA. The public deserves, and biomedical innovators need, a regulatory agency that can match the pace of science, the agility and innovation of the biopharma industry, and the urgency of patients living with unmet medical needs.

This year’s Back to School asks what FDA could look like if it were reorganized from the ground up. Starting with a blank page and setting aside political constraints, how would one design a regulatory agency that keeps pace with scientific advances, earns and retains public trust, and is shielded from shifting political winds? ...