This article was originally published in The Gray Sheet
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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