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Author: Brenda Fulmer

Closing the Loop-Holes in Generic Drug Warnings

03/13/2014
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The Food and Drug Administration is considering some very important changes to its internal rules that would help to eliminate a loophole in accountability for defective drugs.   Under current law, only the brand name manufacturer is permitted to change the warning label for a particular drug.   After a drug is […]

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Swift Pace Welcomed for New Pradaxa MDL

08/20/2012
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The first hearing for the newly-created Pradaxa MDL has been scheduled for October 3, 2012, at 1:30 PM at the United States Courthouse in East St. Louis, Illinois.  On August 8, 2012, the Judicial Panel on Multi-District Litigation (JPML) granted the plaintiffs’ request for establishment of an MDL and assigned […]

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The FDA and the Saga of Multaq — When is enough, enough?

10/24/2011
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There are growing safety concerns over the anti-arrhythmia drug Multaq, (dronedarone), which is manufactured and marketed by Sanofi-Aventis and has generated a great deal of controversy and concern in just a few short years. Multaq was first approved by the Food & Drug Administration (“FDA”) in 2009 for use as […]

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Looking at the Heart Using a Bracco CardioGen-82

10/6/2011
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As depicted in the following video, over the years, cardiologists have relied upon invasive catheterization to diagnose cardiac-related blood flow problems and muscle wall damage. However, placing a catheter into blood vessels and guiding it into the heart is technique-sensitive, and is far more invasive and less diagnostic than the […]

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Smart Moms: Exercise Caution in Using Zoloft

10/4/2011
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Many physical, social, and chemical changes happen to a woman both before and after her pregnancy.  These changes can lead to women suffering from a number of symptoms including depression.  In fact, it has been said that one out of every five women has symptoms of depression during their pregnancy. […]

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Patients Should Reap the Benefits of Data Collected by the FDA

09/30/2011
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Over the past decade, the Food & Drug Administration has made great efforts to provide improved safety information to patients and consumers. The FDA web site includes a number of helpful materials: warning labels, podcasts white papers prepared for scientific panels that summarize complex medical and scientific data Power Point […]

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