Weekly Roundup – 9-1-06

J0403674 Is it me?  Was this a long week or what?  And yet, it is hard to believe that September is upon us.  We now shift our glance to welcome the potential for Fall.  Back to school shopping drives the economy as we begin to anticipate cooler weather.

I hope everyone enjoys a restful Labor Day weekend. 

In the meantime, we keep our focus on what happened this week:

  • A Tissue Task Force – not the paper one, the human one.  The FDA formed a Task Force on Human Tissue Safety.  According to the FDA release "The main priority of HTTF will be to assess the effectiveness of the implementation of the new tissue regulations, which went into effect in 2005. Of particular interest will be a review of recently reported findings that some tissue recovery establishments are not following federal requirements for tissue recovery. "  They will seek to develop an action plan over the next three months.   On a related note, there was a MedWatch alert about this very topic. 
  • Polls Shows Overwhelming Support for Importation – Meanwhile, relating to yesterday’s posting on the importation of drugs from Canada, a Wall Street Journal poll demonstrates widespread support for drug importation.  The poll also had other highly interesting insights and compared it to a baseline poll from 2004, demonstrating some shifts in sentiment that are insightful during an election cycle. 
  • Generic Plavix Nixed by Judge for U.S. – In an interesting development in the on-going issues in bringing a generic version of Plavix to the market, a judge has halted distribution in the United States. 
  • Clinical Trial Workshop – While not the workshop on adaptive clinical trials that everyone is waiting for, the FDA did announce a different workshop being held in November.  It will include both industry and agency perspectives on the proper conduct of clinical trials and will last two days. 
  • Adaptive Clinical Trials Workshop Still Not Announced – On a related note, curiously, no official word on the adaptive clinical trial workshop, about which there has been keen interest judging by the traffic to my postings on this topic.  For that workshop, when announced, there would appear to be a heavy interest, including many from outside the U.S.  I did post on the overall content on this workshop, and as soon as something comes out finalizing, I will post links. 
  • Troubles with E-Mail Subscriptions to Eye on FDA – Feedburner has been experiencing technical problems this week.  If you have an e-mail subscription, I hope that they will resolve the problem this week. 
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