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Clinical & Translational Science Institute / Services and Support / Expanded Access

Expanded Access

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. The University of Rochester has formalized a process for requesting use of a non-FDA-approved investigational drug outside of a clinical trial that expedites the coordination of all groups that need to be involved.

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

  • 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.
  • The potential patient benefit justifies the potential risks of the treatment and those potential risks are not unreasonable in the context of the disease or condition to be treated.
  • 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
  • Office of Research and Project Administration
  • Office of Counsel
  • Research Subjects Review Board

Get Started

To use a non-FDA-approved drug through the expanded access pathway, 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.

Contact

Joan E. Adamo, Ph.D., Director, Regulatory Support
Joan_Adamo@urmc.rochester.edu, (585) 275-0742

Carrie Dykes, Ph.D., Research Engagement Specialist
Carrie_Dykes@urmc.rochester.edu,  (585) 275-0736

Shelby Johnson, Administrative Support
Shelby_Johnson2@urmc.rochester.edu, (585) 275-5327