Q&A with FDA Podcast: Expanded Access with Dr. Jacqueline Corrigan-Curay
Expanded access, aka "compassionate use", 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.
This activity features educational content from the "Q&A with FDA" Podcast Series, produced by FDA's Division of Drug Information. This podcast series addresses some of the most frequently asked questions that we've received at the FDA.
- Discuss the Expanded Access (EA) process.
- Describe the procedures for obtaining access to investigational drugs, biologics, and medical devices.
- Explain what considerations should be made before pursuing Expanded Access.