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iGuard.org Presents New Data on Statins at FDA Workshop Demonstrating How Patient-Reported Information Can Enhance Drug Safety Knowledge
Date:5/7/2008

pected norm. Input from this workshop will be used to develop draft guidance to Industry, and to provide consistent review criteria to use in evaluating protocols and study reports submitted to the agency.

About iGuard.org

iGuard.org, headquartered in Princeton, NJ, is a free and secure source of information for registered users who want to get informed, stay informed and share feedback about their medications. It offers balanced and timely content to help patients manage their healthcare for themselves or loved ones. Registration is free online at iGuard.org.

Editor's Note: The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the FDA hosted today's workshop titled, "Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies using Large Electronic Healthcare Data Sets."
Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Hugo Stephenson http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=67979


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