Invest in ME Conference 12: First Class in Every Way
OverTheHills wraps up our series of articles on this year's 12th Invest in ME International Conference (IIMEC12) in London with some reflections on her experience as a patient attending the conference for the first time.
Discuss the article on the Forums.

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

    Messages:
    341
    Likes:
    375
    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    Contains Nonbinding Recommendations Draft — Not for Implementation

    This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current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.
     
    Woolie, beaker and Esther12 like this.
  2. Esther12

    Esther12 Senior Member

    Messages:
    8,261
    Likes:
    26,607
    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

    Messages:
    773
    Likes:
    1,836
    USA
    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 !!

     
    Valentijn, Esther12 and melamine like this.
  4. melamine

    melamine Senior Member

    Messages:
    341
    Likes:
    375
    Upstate NY
    I haven't read it all yet. It was something I had stumbled on while searching for something else and was rather pleasantly surprised.
     
    Esther12 likes this.

See more popular forum discussions.

Share This Page