Expanded Access

Sometimes called “compassionate use,” expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

FDA has set up several methods to access investigational drugs, biologics, and devices. The agency has outlined these methods for Expanded Access.

Helpful guidance regarding FDA requirements is available:

DRUG – FDA guidance regarding access to Investigational Drugs or Experimental Biologics for Treatment Use (pre-use)

DEVICE – FDA guidance regarding access to Investigational Devices for treatment use (prior to use)

For questions about and requests for emergency use and expanded access for drugs, biologics, devices or to get an emergency IND or IDE, contact FDA:

• Normal Business Hours (8 a.m. - 4:30 p.m. ET, weekdays):
• Drugs: (301) 796-3400 [CDER's Division of Drug Information]
• Biologics: (800) 835-4709 [CBER's Office of Communication, Outreach and Development]
• Devices: (301) 796-7100 [CDRH's Division of Industry and Consumer Education]
• Nights/Weekends: (866) 300-4374 [Office of Crisis Management & Emergency Operations Center]

Emergency Use and Compassionate Use requests involving a single patient should be submitted for review via the Expanded Access Survey.

Non-emergency single-patient expanded access requests should be submitted in ETHOS with a completed FDA Form 3926 (box 10b selected to request a waiver of full IRB review). Additional information regarding submission of these non-emergency requests can be found in the Expanded Access IRB Application Quick Reference Guide, found in HRP-103, Investigator Manual under “What if I need expanded access to investigational drugs, biologics, and devices?” 

The University of Minnesota follows all requirements outlined by FDA when evaluating these uses.