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26 - Expanded Access and Compassionate Use in Alzheimer’s Disease Drug Development
from Section 3 - Alzheimer’s Disease Clinical Trials
- By Diana Kerwin
Edited by Jeffrey Cummings, University of Nevada, Las Vegas, Jefferson Kinney, University of Nevada, Las Vegas, Howard Fillit
Book:

Alzheimer's Disease Drug Development

Published online:

03 March 2022

Print publication:

31 March 2022, pp 301-308
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Summary

Expanded access and compassionate use refer to the use of an investigational new drug outside of a clinical trial to treat a patient with a serious or life-threatening disease who are not eligible or it is not feasible to participate in randomized, clinical trials. The Food and Drug Administration oversees the expanded-access program and provides guidance for the stakeholders. The expanded-access process provides a potential mechanism to facilitate Alzheimer’s disease (AD) drug development process and increase access to investigational new drugs for patients with AD.