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13.09.12 - USA FDA declares ME/CFS is categorised as a “serious or life threatening disease.”


USA FDA declares ME/CFS is categorised as a “serious or life threatening disease.”
 

Dr Sandra Kweder MD, Deputy Director, CDER Office of New Drugs, stated in response to Terry Gilmete

“ We consider your condition to be in the category of serious or life threatening diseases.

Okay, so all of the measures to move things through rapidly, all of the tools that we have here at FDA to try and expedite reviews or expedite development and work with companies to try and encourage them along that would apply to, you know, immediately life threatening cancer, as far as we’re concerned they apply to this condition.

This is a serious condition and I just want to make that clear. We consider it in the same category because there are no approved treatments for this condition and we understand how seriously and severely peoples’ lives are impacted by this disease – by this condition.”

Kim McLeary picked this up saying ” I’m President and CEO of the CFIDS Association of America…….I’m delighted today to hear the clear affirmation from FDA that ME/CFS is considered a serious and life threatening condition and hope that the pharmaceutical and biotech partners on the line will take that as a sign that they should ramp up their efforts to take advantage of the accelerated approval measures that can be utilized or applications under ME/CFS indications.”














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