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Tag Archives: expanded access

A Primer on Compassionate Use

fdaby Kelly McBride Folkers and Lisa Kearns

 

Expanded access, or “compassionate use,” allows patients and their physicians to request from pharmaceutical medical products (drugs, devices, biologics) that have not yet been approved by the U.S. Food and Drug Administration (FDA). There are several steps you and your doctor must take to get access to an unapproved medication, according to the FDA’s Expanded Access Program.

 

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