FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad – sharing news, background, announcements and other information about the work done at the FDA on behalf of the American public.
By Jeffrey Shuren, M.D., J.D.
We know that patients with life-threatening or irreversibly debilitating conditions lack treatment and diagnostic options. For these patients, earlier access to promising new devices is critically important. At the same time, delayed access may mean the difference between life and death, or may result in irreversible disability.
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