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.

Please see full article below for more information.


LOADING PDF: If there are any problems, click here to download the file.

Published In: Administrative Law Updates, Products Liability Updates, Health Law Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Sheppard Mullin Richter & Hampton LLP | Attorney Advertising

×

Expand Your Reach

JD Supra gets your content noticed, increases your visibility and makes your marketing efforts hassle free...

Learn More  or  Schedule a demo