On CAR-Ts, decentralized in-house models, and the hospital exception. Routes for sustainable access to innovative therapies.

"Luca Arnaudo: Italian Medicines Agency, Rome, senior officer; LUISS Guido Carli University, Rome, adjunct professor; Syracuse University College of Law, NY, visiting professor (Spring ‘22). The article represents the opinions of the author and is the product of academic research, it is not meant to represent the position of any of the institutions mentioned above. The author wishes to thank the participants to a faculty research seminar held at the Syracuse University College of Law in February 2022 and to an online seminar held at the Food and Drugs Administration in April 2022, as well as the anonymous peer reviewers, for their insightful comments and suggestions that helped improve this piece. The author has no financial, personal, academic, or other conflicts of interest in the subject matter discussed here."