Guidelines for Expanded Access to Investigational Drugs and Devices

Providing guidance on types of Expanded Access for drugs, biologics, and devices, this content explains the concept of Expanded Access and the criteria that must be met. It covers different types of Expanded Access for drugs and devices, emphasizing the importance of patient safety and benefit. The submission process for Expanded Access requests is also detailed.

• Guidelines
• Expanded Access
• Investigational Drugs
• Biologics
• Devices

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1. EMERGENCY USE & EXPANDED ACCESS EMERGENCY USE & EXPANDED ACCESS MAY 3, 2023

2. Objectives To provide guidance for investigators and study teams on types of Expanded Access for drugs and biologics. To provide guidance to investigators and study teams on types of Expanded Access for Devices To provide guidance for investigators and study teams on IRB resources for both Expanded Access of drugs or devices and Kuali submission. 2

3. What is Expanded Access Expanded Access allows for the use of an unapproved investigational drug, biologic, or device (test article) to treat a patient who does not have a comparable alternative therapy or has exhausted all options to treat a disease or condition. The intent is treatment, not research. 3

4. Criteria for Expanded Access All of the following conditions must exist to justify the expanded access of an unapproved investigational drug, biologic, or device: The patient has a life-threatening or serious disease or condition; There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; and Potential patient benefit justifies the potential risks of the investigational device. Patient taking the investigational medical product will not affect the investigational trials (drugs/biologics only). 4

5. Types of Expanded Access for Drugs & Biologics Expanded Access Intermediate Group Large Patient Group Single Patient Non- Emergency Use Emergency Use Physician Submits to FDA Sponsor Submits to FDA Physician Submits to FDA Sponsor Submits to FDA Sponsor Submits to FDA Physician Submits to FDA 5

6. Types of Expanded Access for Devices Expanded Access Compassionate Use Emergency Use 6

7. Submitting a EUTA Expanded Access Categories Use of an Unapproved Drug or Biologic: Emergency Use for a Single Patient Non-Emergency Use for an Individual Patient Non-Emergency Use for an Intermediate-Size Patient Group Use of an Unapproved Medical Device: Emergency Use for a Single Patient Compassionate Use for a Single Patient All requests for expanded access should be submitted via Kuali; select Expanded Access to a Test Article as the protocol type. 7

8. Resources Guidance on Expanded Access to Test Articles FDA Introduction to Expanded Access EXPANDED ACCESS TO TEST ARTICLES website link: https://www.lsuhsc.edu/administration/academic/ors/irb/exp anded_access.aspx 8

9. Save the Date! Date Time Topic 06/07/2023 12:00PM Non-Human Subjects Research Determinations 07/05/2023 12:00PM Reliance 9

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