This article was originally published in The Gray Sheet
Executive SummaryHealth 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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