Comment from Elissa Gentry

Summary: The commenters, representing academic and medical institutions (Arizona State University, Toulouse School of Economics, and Harvard Medical School), support the FDA's move toward a "plausible mechanism" framework for N-of-1 therapies but argue it should move further toward a service-based model. They advocate for replacing one-time premarket approval with continuous oversight and mandatory data sharing to address the unique challenges of individualized genetic treatments.