Voices from the Shadows, on September 29, 2012:
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.” Read more>>
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