Expanded access refers to the use of an investigational drug outside of a clinical trial by patients with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. This type of access may be available, in accordance with United States Food and Drug Administration (FDA) regulations, when it is clear that patients may benefit from the treatment, the therapy can be given safely outside the clinical trial setting, no other alternative therapy is available, and the drug developer agrees to provide access to the drug. The FDA refers to such a program as an expanded access program (EAP). EAPs can be leveraged in a wide range of therapeutic areas including HIV/AIDS and other infectious diseases, cancer, rare diseases, and cardiovascular diseases, to name a few.
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Some articles on expanded access:
... NCI) Expanded access Refers to any of the FDA procedures, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to ... NLM) Expanded access trial A way to provide an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious ... Expanded access allows a patient to receive promising but not yet fully studied or approved therapies when no other treatment option exists ...
... programs that enable access to drugs in the pre-approval and pre-launch phase are referred to by a variety of names including “named patient programs,” “named patient supply” and “temporary ...
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