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FDA: Guidance for Industry CFS/ME - nonbinding recommendations

Discussion in 'Other Health News and Research' started by melamine, Jan 20, 2015.

  1. melamine

    melamine Senior Member

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    Upstate NY
    http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm388568.pdf

    March 2014

    Guidance for Industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment

    Contains Nonbinding Recommendations Draft — Not for Implementation

    This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current
    thinking on this topic. It does not create or confer any rights for or on any person and does not operate to
    bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of
    the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA
    staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
     
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  2. Esther12

    Esther12 Senior Member

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    Anything good or bad in it?

    I have to admit, I misread the title I thought this was going to be all about nonblinded trials!
     
  3. beaker

    beaker ME/cfs 1986

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    1. {my emphasis}

      I couldn't read all. But so far it sounds like they are on the ball.
      I remember their conference went well.
      Now they need to implement this and not just have it as a draft !!

     
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  4. melamine

    melamine Senior Member

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    I haven't read it all yet. It was something I had stumbled on while searching for something else and was rather pleasantly surprised.
     
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