Weekly Roundup – 03/21/08

Cg54Well, Congress was away this week, so the city was less crowded and altogether more pleasant.   The drive to work – a dream.  Spring sprang on Thursday.  I was very busy this week and am very much looking forward to the weekend.

Meanwhile, here is a bit of what happened this week:

  • Approvable Letter Issued – In addition to the approvable letter reported on earlier this week, the Boston Globe reported that Boston Scientific received an approvable letter for its Taxus Liberté stent.  There was no press release on the company’s Web site, nor did the Boston Globe interview the company, and the FDA of course would not offer comment.  Therefore there is no word on the reasoning for the approvable status. 
  • FDA Re-designs Home Page – Not exactly headline news, but the FDA has created a new home page. The re-design does move several of the home page items around and some of the links have been changed, so it may take you to more time to find some of the things that were once only one click away.   On the home page, there is a link to take you to a page that explains the new page.  Under the heading "Why We Changed the Home Page?" the first line says "In a nutshell, we listened to you."  Ok, I wish.  Listen to this, spend less time on the Home Page and more time on your image and leadership. 
  • FDA Nearer to Establishing a Presence in China – Speaking of listening, in the wake of the Heparin troubles and the possible link to China, the FDA announced this week that the agency is "on the path" to establishing offices in China.   That is the headline and then the first line of the press release announces that they are going to hire 8 new people for China.  8?  And, this is pending Chinese government approval.  I think this is meant to provide comfort, I’m not sure it does.   
  • Advisory Committee Meeting Scheduled After an Approvable Letter is Issued – On January 30, Lev Pharmaceuticals received an approvable letter from the FDA requesting more information on its investigational product Cinryze(TM) (C1 inhibitor) for both the acute and prophylactic treatment of hereditary angioedema (HAE), or C1 inhibitor deficiency.    The agency asked for information with respect to chemistry, manufacturing, and controls (CMC), as well as additional analyses of existing efficacy data from the Cinryze(TM) trials.  Then, a happy milestone for the company.  the company announced that the Blood Products Advisory Committee will be reviewing the BLA on May 2.

That’s it for this week.  Have a good weekend everyone!  

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One Response to Weekly Roundup – 03/21/08

  1. Kerry says:

    Approvable letters and denial letters functionally act in the exact same way.
    The FDA created approvable letters only as a mechanism to avoid Congressional and Court oversight.
    Its a con job on America!
    Houdini would be proud of that trick!
    Gotta hand it to FDA counsel though, they have done their job well.