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Thread: FDA Dramatically Simplifies its Compassionate Use

  1. #21
    Senior Member lynnifer's Avatar
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    Quote Originally Posted by Barrington314mx View Post
    Isnt Jerry Silvers latest work some form of drug? If yes, couldnt that apply here?
    His research is exciting, but the drawback is how far he needs to go. The research is in its infancy.
    Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

    T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

  2. #22
    Quote Originally Posted by nonoise View Post
    Really? Does one have to be terminally ill to qualify for compassionate use?
    \

    edit:
    Found my own answer, no need to be terminal:
    http://www.mayoclinic.org/healthy-li...e/faq-20058036
    You are right

    From the FDA:

    Expanded Access Requirements For Individual Patient Access to Investigational Drugs (Including Biologics): What You Need to Know

    Participation

    • The patient and his or her licensed physician must both be willing to participate.
    • The patient must:

      • Have a serious or immediately life-threatening disease or condition;
      • Have no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; and
      • Be unable to obtain the investigational drug under another IND or to participate in a clinical trial.


    http://www.fda.gov/NewsEvents/Public...s_Requirements

    It seems that as soon as a therapy show some indications of efficacy people in the US have a way to get it before the completation of clinical trials and market approval and now the paperwork needed is much easier.

    I wonder if people who like the FDA the way it is would say it was better the previous paper work process..

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  3. #23
    Quote Originally Posted by lynnifer View Post
    His research is exciting, but the drawback is how far he needs to go. The research is in its infancy.
    I wish we had a whole lot more research projects showing efficacy that were making it's way satisfactorily through the well known valley of death.

  4. #24
    Super Moderator Sue Pendleton's Avatar
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    When Fidia Inc was still in the US chronic SCIs could get Sygen outside of their acute tria,ls with a compassionate use exception.
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

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