Weekly Roundup -9-8-06

J0400760 Well, it is time for the Weekly Roundup.  It is back to school and back to Congress.  For the rest of the world that means more activity, the end of fun and a different way of life.  For those of us in the Beltway in Washington, D.C., it means one thing – a tougher commute.   

Yes, the Congress is back.  They had so much of nothing that they didn’t do, they came back to not do some more. 

In the meantime, things were busy on the FDA front.  Here’s what happened this week:

  • Dietary Supplements Seized for Health Claims – In a move with message for dietary supplements that make unauthorized claims, the FDA seized product.  It was stated in the FDA press release that the " labeling promotes and markets these products for serious disease conditions, including but not limited to cancer, arthritis, fibromyalgia and seizure."  As such, the FDA felt that the claims were drug claims. 
  • New Draft Guidances on Medical Testing – The agency issued a draft guidance for industry and labs on group of medical tests.   The subject tests involve In Vitro Diagnostic Multivariate Index Assays (IVDMIAs).  The Federal Register notice on this guidance can be located here.  The agency also introduced a new draft guidance on active ingredients used in medical testing.  The Federal Register notice on this guidance can be located here
  • Heart Implant Device Approved – The first totally implantable heart device was approved for patients with advanced heart failure involving both pumping chambers of the heart.  Made by Abiomed, Inc. (Danvers, Mass.), is intended for people who are not eligible for a heart transplant. 

Have a rootin’ tootin’ weekend folks. 

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