Weekly Roundup – 04/25/08

J0403681The pollen is so thick, not even the Hot Air from Capitol Hill can blow it away.  My black car is perpetually yellow-coated.  Everywhere you look, blooming this and blooming that.  Even my contact lenses have a film on them!  It has been a long, hard week, beginning where I sliced off part of my index finger…. a auspicious beginning.  (Did you know that your finger print grows back?) 

But it is the end of the week now, so let’s have another Weekly Roundup!

  • Viewing YouTube Videos – By the way, if you receive Eye on FDA through a subscription service, you may not be able to view the YouTube insertions.  Therefore to see them, you’ll have to come directly to the site www.eyeonfda.com
  • Testimony on the Hill – Stephen F. Sundlof, D.V.M., PH.D., Director of the Center for Food Safety and Applied Nutrition provided testimony this week before the Subcommittee on Health Committee on Energy and Commerce about the food and cosmetic provisions of the Food and Drug Administration Globalization Act draft legislation where he essentially provided an overview of steps that the FDA has taken to ensure safety. 
  • Really Bad Report Card on Post-Marketing Studies – This is about the last thing that industry needs right now, but the FDA has released the latest figures on how well industry has kept to post-marketing commitments and it isn’t good news.  Bloomberg reports that agency "determined that 1,044, or 62 percent, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn’t begun…" – Look for more on that in the upcoming FDA reform package from Capitol Hill.
  • Shire Vyvance Gets Approval for Adults – After a year where so many ADHD treatments have gotten approvable letters rather than approvals, the FDA has approved Shire’s Vyvance, previously approved for use in children, for use in adults. 
  • FDA Commissioner von Eschenbach Grilled on the Hill by Dingell – What’s for lunch?  Grilled Commissioner. 

That’s it folks. Have a good weekend!

 

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One Response to Weekly Roundup – 04/25/08

  1. Kerry Donahue says:

    Andy needs to be grilled on a lot more topics including the Provenge debacle.
    Ask him why he let Pazdur saboage the Provenge BLA and then when CBER was pushing for approval how he let Pazdur extort CBER and Andy into giving Provenge up in the name of politics.
    Andy allowed the FDA to sell out AIPC patients and refuses to answer questions on the topic.
    More on this sorid affair at http://www.CareToLive.com.