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AUTOLOGOUS CELL PRODUCT REGULATION BY FDA SHOULD FOCUS ON MANUFACTURING PROCESSES, STANDARDIZED DATA COLLECTION; 10-YEAR FOLLOW-UP RECOMMENDED

This article was originally published in The Gray Sheet

Executive Summary

FDA does not plan to impose premarket requirements on autologous cell products used for structural repair, agency staffers indicated at a Nov. 16-17 workshop in Gaithersburg, Maryland. Instead, the agency likely will focus on industry recommendations to help ensure quality tissue manufacturing and uniform post-market testing standards.
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