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: ClassLawBlog.com

LabCorp Warned About Marketing Ovarian Cancer Test

By classlawblog

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According to Medical News Today, on September 29, 2008, the U.S. Food and Drug Administration (FDA) issued a warning letter to the global clinical network, LabCorp for illegally marketing the ovarian cancer test, OvaSure.

In the warning letter, the FDA states LabCorp is in violation of the Food, Drug, and Cosmetic Act because the company does not have marketing clearance or approval from the FDA to market OvaSure.  Within fifteen days of the receipt of the warning letter, LabCorp is required to notify the FDA of the specific steps the company has taken to correct the noted violations and the steps taken to prevent the recurrence of similar violations.

Full post as published by ClassLawBlog.com on October 14, 2008 (boomark / email).

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