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26 - Expanded Access and Compassionate Use in Alzheimer’s Disease Drug Development

from Section 3 - Alzheimer’s Disease Clinical Trials

Published online by Cambridge University Press:  03 March 2022

By
Diana Kerwin
Edited by
Jeffrey Cummings ,
Jefferson Kinney  and
Howard Fillit
Jeffrey Cummings
Affiliation:
University of Nevada, Las Vegas
Jefferson Kinney
Affiliation:
University of Nevada, Las Vegas
Howard Fillit
Affiliation:
Alzheimer’s Drug Discovery Foundation
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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.

Keywords

Expanded AccessInvestigational New DrugUS Food and Drug AdministrationRight To TryCompassionate Use
Type
Chapter
Information
Alzheimer's Disease Drug Development
Research and Development Ecosystem
 , pp. 301 - 308
Publisher: Cambridge University Press
Print publication year: 2022

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References

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