The Call for Opposition: Challenging the P2P and IOM Processes
In our second article on how to react to the publication of the draft P2P report, Gabby Klein provides her view of why she and a large group of advocates and patients are continuing their protest of the government’s ongoing control and manipulation of our disease via their processes...
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FDA Basics Webinar: Biologic Drugs

Discussion in 'General ME/CFS News' started by jspotila, Jun 15, 2013.

  1. jspotila

    jspotila Senior Member

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    For anyone interested, FDA is offering an FDA Basics webinar on Monday, June 17 at 1pm EDT on Biologic drugs. Rituximab and Ampligen are two examples of therapeutic biologics. The webinar will provide an overview of these kinds of projects. No registration is required, and you can join the webinar through a link on this page:

    http://www.fda.gov/AboutFDA/Transparency/Basics/ucm355978.htm
     
    SpecialK82, Bob, SOC and 2 others like this.
  2. Chris

    Chris Senior Member

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    Victoria, BC
    Jennie, thanks for this info--sounds interesting, since I don't really understand how either of these drugs work. Chris
     
  3. Sherlock

    Sherlock tart cherry etc. for joints, insomnia

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    Czechosherlockia, USA
    It was a nice primer, around 20 minutes. The audio is supposed to be up in 2 days. The next one on biosimilars is August 19th. Thanks to jspotila for the alert on this webinar.

    As always, the question/answer period afterwards was disappointing because of what questions get chosen, such as "will the slides be available?" (the link to the slides was right there before the webinar, right next to the very link that you had to use to get to the webinar presentation page). http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM356666.pdf
     
  4. Sherlock

    Sherlock tart cherry etc. for joints, insomnia

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    Czechosherlockia, USA
    Hi, Chris. Nothing was said about how they work, which varies a lot anyway. It was mainly about the difference in complexity... also in size and shell life, etc.

    FYI, the rituximab antibodies work like tiny little flags that are engineered to attach to the B-cells, and they signal other parts of the immune system to come kill this thing. The same could be done for invading bacteria, e.g.
     
  5. Chris

    Chris Senior Member

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    Victoria, BC
    Sherlock, thanks for this--I managed to miss it--having a low day. Sounds as if I did not miss too much, anyway. Now on to see how the planned Rituximab studies work out--I wish us all good luck! Chris
     

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