The departure of Dr. Vinay Prasad, a high-profile FDA regulator known for his strict adherence to traditional clinical trial standards, has renewed debate about how the agency should balance scientific rigor with timely patient access to emerging therapies.

Rather than framing this moment as a binary choice between rigor and access, stakeholders should recognize it as an opportunity to advance a more integrated evidentiary model that reflects both controlled science and real-world patient outcomes.