This online learning activity discusses expanded access, which is a pathway to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative treatment options are available. This activity will address questions about the expanded access process and the procedures for obtaining access to investigational drugs, biologics, and medical devices.

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.

• Expanded Access website: https://www.fda.gov/news-events/public-health-focus/expanded-access
• Reagan Udall Foundation Expanded Access Navigator website: https://erequest.navigator.reaganudall.org/#/home/landing

• 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.

Physicians, physician assistants, pharmacists, nurses, pharmacist techs, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

• Corrigan Curay, Jacqueline, MD, JD, Director Office of Medical Policy, CDER - nothing to disclose

• Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
• De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
• Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
• Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose

• Bueide, Rachel E., MPhil, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose

Initial Release Date
September 29, 2023

Expiration Date
September 28, 2026