Navneet Majhail: 80/20 effort to reduce REMS burden for Cell Therapy treatment centers
Navneet Majhail, Physician-in-Chief of Blood Cancers at Sarah Cannon, shared a paper Frederick L. Locke and colleagues authored on LinkedIn:
“Kudos to the work by ASTCT 80/20 effort to reduce REMS burden for Cell Therapy treatment centers.
Highlights include:
– Significant collaborative efforts have led the FDA to curtail CAR-T REMS programs.
– Society guidelines and center practices should replace prior REMS requirements.
– Aggregating standardized data in a single repository tracks safety more effectively.
– Accrediting bodies may allow manufacturers to relinquish some oversight tasks.
– Inexperienced centers and emerging toxicities require nimble oversight approaches.
Appreciate the leadership of Frederick Locke, Sarah Nikiforow, Miguel-Angel Perales, Krishna Komanduri, Matthew Frigault, Partow Kebriaei, Zahra Mahmoudjafari, and many others who participated in this multi stakeholder initiative.”
Authors: Frederick L. Locke et al.
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