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MAS CELL PRODUCT MANUFACTURER REGISTRATION DUE BY LATE NOVEMBER, IND/BLA IN 18 MONTHS, FDA SAYS; SHORT-TERM DATA GENERALLY ACCEPTABLE TO SHOW EFFICACY

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers of autologous cell products for structural repair must register as drug manufacturers with FDA by the end of November, according to the agency's plan for regulating the products. The policy covers products comprised of living autologous cells manipulated ex vivo and intended for structural repair or reconstruction (MAS cells).
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