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This article was originally published in The Gray Sheet

Executive Summary

Relaunch of Adcon-L outside the U.S. is slated for June 2001, assuming completion of manufacturing validation runs, company announces April 18. Gliatech has received a recommendation for ISO 9001 recertification following a successful European audit. The company recalled its Adcon-T/N and Adcon-L gel lines in January due to a supplier recall (1"The Gray Sheet" Jan. 15, 2001, p. 23). U.S. relaunch of Adcon-L is contingent on "submission and approval of the additional data identified as part of the FDA's Application Integrity Policy status," the release notes

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