Clinical Investigators Beware: FDA is Reviewing What You Say

While it is common knowledge that the Food and Drug Administration (“FDA”) is being more active in its review of prescription drug advertising by drug product manufacturers, it may not be widely known that FDA is reviewing what clinical investigators are stating about drugs for which they served as an investigator and which are not yet FDA approved. Recently, FDA posted on its website a Notice of Violation Letter sent January 11, 2010, to Dr. Leslie Baumann of the Baumann Cosmetic and Research Institute. The letter – coded MACMIS #18181 – can be found here.

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