(U.S.) A Primer on Compassionate Use - Cancer Knowledge Network

Cancer Knowledge Network

 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.....

For more information on the FDA’s Expanded Access policies, visit: http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm

The NYU Langone Medical Center’s Working Group on Compassionate Use and Pre-Approval Access has a relevant FAQ: http://www.med.nyu.edu/pophealth/divisions/medical-ethics/compassionate-use/nyu-working-group-compassionate-use-pre-approval-access