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Expanded Access

**New**: Expanded Access - The process for requesting use of a non-FDA-approved, investigational drug outside of a clinical trial setting has been formalized at the University of Rochester.  This Expanded Access process has a REDCap Application to expedite the coordination of all groups which need to be involved.

Expanded access, sometimes called compassionate use, is the use of an investigational medical product (that has not been approved by the FDA) outside of a clinical trial. The FDA allows these uses on a case-by-case basis, when submitted by a qualified physician.

In order for the FDA to permit expanded access to an investigational drug, the following criteria (found in 21 CFR 312.305(a)) must be met:

  1. the patient to be treated has a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition;
  2. the potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated; and
  3. providing the investigational drug for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.

This process involves the careful coordination of information with several groups at the University:

  • Office of Regulatory Support (ORS)
  • Office of Research and Project Administration (ORPA)
  • Office of Counsel
  • Research Subjects Review Board (IRB)

Apply for Expanded Access

To use expanded access, please submit an Expanded Access Application.  Someone from the Office of Regulatory Support will be in touch with you soon to provide assistance so that the regulatory process and reporting obligations are understood and fulfilled.