U.S. flag An official website of the United States government
  1. Home
  2. News & Events
  3. Public Health Focus
  4. Expanded Access
  5. Expanded Access | Information for Institutional Review Boards (IRBs)
  1. Expanded Access

Expanded Access | Information for Institutional Review Boards (IRBs)

On this page, you will find information about:

What is expanded access?

Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or immediately life-threatening 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.

When seeking expanded access to an investigational medical product, it is critical that the patient and his/her licensed physician consider all possible risks. Investigational medical products have not yet been approved or cleared by FDA and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.

Whenever possible, an investigational medical product should be used as part of a clinical trial. However, if patient enrollment is not possible (e.g., patient ineligibility, lack of ongoing clinical trials) or enrollment in a clinical trial is not feasible (e.g., distance to a trial precludes access), expanded access offers a possible route for gaining access to an investigational medical product.

FDA is committed to increasing awareness about its expanded access process and the procedures for obtaining access to investigational drugs, biologics, and medical devices.

Learn more about expanded access categories for drugs and biologics.

Learn more about expanded access categories for medical devices.

  1. Patient
    Consults with licensed physician to explore and decide about alternative options.
  2. Licensed Physician
    Agrees to oversee the patient's treatment and works with industry (e.g., medical product developer), files paperwork with FDA and IRB (for many expanded access request types), and is responsible for patient care and reporting.
  3. Company (Industry)
    Willing to provide the investigational medical product and either submits the expanded access request to FDA, allows the FDA to cross-reference their IND (for drugs and biologics) or IDE (medical devices) on behalf of the expanded access sponsor-investigator through the use of a letter of authorization, or provides the necessary investigational medical product information for the sponsor-investigator to submit to support an expanded access request.
  4. Institutional Review Board (IRB)
    Reviews expanded access protocol and consent to ensure that the patient is informed about the nature of the treatment.
  5. FDA
    Reviews the expanded access request and determines if the treatment may proceed.


Additional Resources

Guidance Documents
Learning Resources
How to Locate an Available IRB

 

 
Back to Top