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Expanded Access Programs

Expanded access, also called “compassionate use,” provides a pathway for patients to gain access to investigational drugs, biologics or medical devices outside the clinical trial setting for treatment purposes.

Drugs that are being scientifically tested but have not yet been approved by the United States Food and Drug Administration (FDA) are called investigational drugs. Being permitted to use one of these drugs outside of a clinical trial specifically designed to study that drug may be commonly referred to as “compassionate use.” 

FDA Expanded Access information

For information on expanded access studies visit the participating programs below.


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