Recent cases of treatments for single patients have the US Food and Drug Administration hurrying to put together policy of how to handle applications for truly personalized medicines.
Now It Really Is Personal: US FDA 'Rushing' To Develop Policy For 'Bespoke Therapies'
Recent cases of individual designed treatments have FDA playing a bit of catch up. The concept has been on the horizon, but now “bespoke therapies” are here.

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A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.