Chapter 34

For Review of Single-Patient Expanded Access

WCG IRB does not charge for review of single patient treatment use of a drug or device.

FDA maintains a 24-hour phone number for questions about emergency and compassionate use: Office of Crisis Management & Emergency Operations Center: 866-300-4374.

The Process for Single-Patient Expanded Access Requests (Drugs/Biologics)

Single-patient expanded access requests are processed differently, using the following process:

  • Please submit FDA Form 3926, the same form that is submitted to the FDA to request the single-patient IND, as well as other appropriate submission forms (HRP-280 for emergency use, HRP-282 for other single-patient expanded access).
  • In accordance with FDA guidance, the request can be reviewed by an IRB Chair and does not need to go to the full IRB. Responses to complete single-patient expanded access review requests are usually returned within 24 to 48 hours of receipt.
  • Because there is no protocol sponsor, WCG IRB does not charge a review fee for single-patient expanded access review — there is no additional burden on the patient.
  • For questions about submitting single-patient expanded access requests, please contact clientcare@wcgclinical.com.

WCG IRB does not provide review for pre-approval access to investigational products that do not follow the FDA’s Expanded Access process.

Additional Resources

In 2019, the FDA created Project Facilitate, a pilot project to assist physicians and patients with understanding and negotiating the process of expanded access for oncology products.

The FDA has created a Q&A document with information about treatment use for investigational products.

Expanded Access for Medical Devices

The process for obtaining approval to use an investigational medical device outside a clinical trial is very similar to that for obtaining an investigational drug or biologic. For devices, single or small treatment group access is called Compassionate Use, whereas the process for a large treatment group is referred to as a Treatment IDE (Investigational Device Exemption).

The IRB review process for single patient compassionate use requests is the same as for single patient expanded access for drugs. The following WCG IRB forms should be used for submission of these requests:

For questions about submitting investigational medical device requests, please contact clientcare@wcgclinical.com.

Additional References

Emergency Useof an Investigational Drug or Biologic – Information Sheet

Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers

Expanded Access: Information for Physicians

FDA’s Guidance on IDE Policies and Procedures, Expanded Access for Medical Devices