Expanded Access to Drugs/Biologics

Overview

All Expanded Access pathways (except emergency use) require prospective FDA and IRB approval prior to administration of the investigational product. Expanded Access treatment with an investigational drug or biologic includes the following IND submissions:

• Single Patient IND
  • for treatment of one patient
  • includes Emergency Use requests
• Intermediate-size Patient Population IND
  • for treatment of more than one patient but fewer than are treated under a typical treatment IND
• Treatment IND
  • for widespread use

See FDA Guidance on Expanded Access Categories for Drugs/Biologics for more information, including criteria and submission requirements.

Submitting to the Stanford IRB

Expanded Access protocols for non-emergency treatment with a drug/biologic should be submitted to the IRB via eProtocol. The submission should include FDA documentation of the IND authorization. Single Patient IND request are generally limited to a single course of therapy for a specified duration. However, FDA may authorize multiple courses of therapy or chronic therapy under the Single Patient IND.

Additional Sponsor Investigator training may be required if the Stanford Investigator is the sponsor of the IND. For information on this training requirement, contact Spectrum at regulatory-spectrum@lists.stanford.edu.

Form 3926 is typically submitted to the FDA for non-emergency Single Patient IND requests. To allow for IRB Chair or designated member approval (concurrence) rather than review at a convened IRB meeting, a request for alternative IRB review procedures should be selected in section 10b of Form 3926. 

Consent

Informed consent for expanded access treatment should be obtained in accordance with FDA regulations under 21 CFR 50.20. Use the Regular Consent with HIPAA template, revising the consent form to reflect the expanded access treatment program and removing references to "research".

Other Considerations

 Note that other Ancillary & Institutional Reviews may be required in addition to IRB approval.

FDA Guidance and Contact Info

• Expanded Access - Information for Physicians
• Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
• Expanded Access Categories for Drugs (Including Biologics)
• FDA's Expanded Access Contact Information

See Other Types of Expanded Access

Page updated October, 2025