Statement from FDA Commissioner Robert Califf, M.D. on the release of the final individual patient expanded access form

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Title: Statement from FDA Commissioner Robert Califf, M.D. on the release of the final individual patient expanded access form

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Statement from FDA Commissioner Robert Califf, M.D. on the release of the final individual patient expanded access form

06/02/2016 09:05 AM EDT

Today, the U.S. Food and Drug Administration finalized its efforts to streamline the process used by physicians to request expanded access, often called “compassionate use,” to investigational drugs and biologics for their patients. As a physician, I understand the importance of being able to access investigational treatments for a patient when there are no other options to treat their serious disease or condition.

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