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Market Access

Expanded Access Program

What is an Expanded Access Program?
An expanded access program allows for patients and providers to get access to a drug that is not yet approved for a specific use outside of enrolling in a clinical trial. Also called “compassionate use”, it allows patients who may not qualify for or disinclined to join one to get access to a potentially life-saving or impactful drug nonetheless. The FDA has to approve specific applications for expanded access. An institutional review board (IRB) may also be required to approve expanded access requests in many cases.