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. 2017 Mar 1;51(2):177-179.
doi: 10.1177/2168479017694850.

Overview of FDA's Expanded Access Program for Investigational Drugs

Jonathan P Jarow  1 , Peter Lurie  2 , Sarah Crowley Ikenberry  1 , Steven Lemery  1
Affiliations

Overview of FDA's Expanded Access Program for Investigational Drugs

Jonathan P Jarow et al. Ther Innov Regul Sci. .

Abstract

Expanded access, also called "compassionate use," provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials. The US Food and Drug Administration (FDA) facilitates the expanded access process; however, access to investigational treatments requires not only FDA's review and authorization but also the active involvement and cooperation of other parties, including drug companies and health care providers, in order to be successful.

Keywords: expanded access; investigational new drug; investigational therapies; single patient expanded access.

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Conflict of interest statement

Declaration of Conflicting Interests No potential conflicts were declared.

References

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