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CellPro petitions FDA to deny approval of Baxter's Isolex stem cell separation product.

This article was originally published in The Gray Sheet

Executive Summary

BAXTER 8SOLEX 300 PMA APPROVAL REQUIRES PROOF OF CLINICAL UTILITY, CELLPRO SAYS in a Feb. 6 petition to FDA. Seeking to farestall approval of the Baxter's stem cell separation system, Cellpro states: "It appears that no proof of clinical utility for the Isolex 300 has been presented such as that required of CellPro and that FDA may not require such proof in the PMA for the Isolex 300 system." CellPro markets the Ceprate SC stem cell concentration system.
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