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AUTOLOGOUS CELL PRODUCT QUALITY ASSURANCE PROCEDURES CAN BE FLEXIBLE, FDA SAYS IN GUIDANCE; DOCUMENT ACKNOWLEDGES UNIQUE NATURE OF SOME MAS PRODUCTS

This article was originally published in The Gray Sheet

Executive Summary

Autologous cell product manufacturers may use flexible acceptance criteria and specifications in certain quality assurance procedures in order to accommodate the unique nature of some cell therapy products, FDA says in a new guidance document on premarket requirements for autologous somatic cell therapy products.
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