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FDA Eases REMS and Monitoring Rules to Improve CAR-T Access

Published on LinkedIn via Spencer Knight


The FDA has updated CAR-T therapy regulations for BMS’ Abecma and Breyanzi, removing REMS requirements and reducing monitoring burdens. These changes are expected to improve patient access, especially in underserved regions where families previously had to travel long distances to certified treatment centers. With lower post-treatment proximity requirements and shorter driving restrictions, CAR-T may soon become more accessible in community hospital settings across the U.S.


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