Weekly Roundup – 8/11/06

J0179122 Another week of dog days of summer have past.  (The term, by the way, dog days of summer is related to the fact that Sirius, the dog star, is out during this time and rises and sets with the sun.  It has nothing to do with your pet.)

In terms of other things we are interested in, here is what happened:

  • Long-heralded Kennedy Enzi bill finally dropped – After a seriously long drum-roll, the bill called S.3807 was finally introduced.  It’s aim is to reform the FDA around issues of drug safety and there will be more on this later.  Note that a link has also been added to the right sidebar of this blog under Proposed Legislation. 
  • From Star Trek to the FDA – Nanotechnology – Perhaps wanting to get into the next Star Trek series, the FDA has formed a Nanotechnology Task Force.  Failing a TV career, the task force will explore the uses and limitations of the technology for the future.  A docket will be opened. 
  • Medical Device Comments Sought – Appearing in today’s Federal Register, the agency issued a press release to let it be known that it is looking for public comment on use of an identifier system for devices.  A docket will be opened. 
  • Clinical Trials Workshop – Apparently not related to the Adaptive Clinical Trials meeting (see yesterday’s posting), immediately after that workshop, the FDA is holding another meeting, this time in Indianapolis on clinical trials, also according to a Federal Register posting. 
  • More Generics on the Way – The FDA approved generic Effexor (venlafaxine), indicated for the treatment of major depressive disorder (MDD).  The manufacturer will be Teva Pharmaceuticals. 

Have a good weekend everyone.  I’ll be reporting next week from Toronto on site at the XVI International AIDS Conference. 

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