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This article was originally published in The Gray Sheet

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Executive Summary

Health Policy Associates hired as independent auditor to assist firm in responding to FDA's Application Integrity Policy (AIP) letter questioning post-market data for the Adcon-L gel anti-adhesion product for lumbar surgery. FDA recently suspended review of one premarket approval application and two PMA supplements submitted by the firm (1"The Gray Sheet" Jan. 1, 2001, p. 5)
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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