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RTI Pooling Methods Conflict With Tissue Practices Rule - CBER

This article was originally published in The Gray Sheet

Executive Summary

Regeneration Technologies, Inc.' s BioCleanse system for pooling tissue from multiple donors is not validated to conform to FDA's Jan. 8 proposed rule on good tissue practices, FDA states in a May 3 letter to the firm.

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Tissue pooling

FDA's Center for Biologics Evaluation and Research will not take regulatory action against Regeneration Technologies while it is reviewing additional data on the Alachua, Florida firm's BioCleanse tissue sterilization system, according to a May 16 CBER letter. The center issued an untitled letter to RTI May 3 informing the firm that the BioCleanse did not conform to FDA's proposed rule on current good tissue practice, which prohibits pooling tissue from multiple donors during manufacturing (1"The Gray Sheet" May 14, 2001, p. 8)

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