Guidance from FDA

This Wednesday, FDA will host an informational webinar about the Draft Guidance to Industry on Drug Development for ME/CFS. I hope you can attend and learn more about the Guidance document, because public comments are due May 12, 2014! This document is the major outcome from last year’s Drug Development meeting, and it is really critical that we provide our input before the document is finalized.

I will post a summary of the webinar and my own public comments on the document by the end of the week (I hope!).


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3 Responses to Guidance from FDA

  1. Ren says:

    As always – Thank you, Jennie (and to all who help the neuro-immune community).

  2. kathy d. says:

    This is very interesting. It intrigues me that the FDA will host a webinar on guidelines for the drug industry for treatments for ME/CFS, when the government has not even decided that this is a “real disease” with physical causes and biomarkers. If it still claims it is psychological in origin and all we sufferers have to do is CBT and GET and “pace” ourselves (as if we all don’t do that!), and presto — we’ll be fine, how can it recommend medications?

    I hope it’s not various versions of “speed” in some form. That’s all we would need — not!

    I look forward to your summary and comments at the end of the week, always valuable.

    • Jennie Spotila says:

      FDA has really been at the forefront in the last few years in trying to advance treatments for us. FDA recognizes ME/CFS as a serious disease, and notes in the Guidance that there is a serious unmet medical need for treatments.

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