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FDA Advisory Committee Review of Supplemental Indications and Reasons for Non-Approval, 2008-2022

Published online by Cambridge University Press:  08 April 2025

Audrey D. Zhang Open the ORCID record for Audrey D. Zhang [Opens in a new window] ,
Nikhil Chaudhry ,
Reshma Ramachandran Open the ORCID record for Reshma Ramachandran [Opens in a new window] ,
Joseph S. Ross  and
Jason L. Schwartz
Audrey D. Zhang*
Affiliation:
Division of General Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Nikhil Chaudhry
Affiliation:
Harvard Law School, Cambridge, Massachusetts, United States
Reshma Ramachandran
Affiliation:
General Internal Medicine, Yale School of Medicine, New Haven, Connecticut, United States
Joseph S. Ross
Affiliation:
General Internal Medicine, Yale School of Medicine, New Haven, Connecticut, United States Department of Health Policy and Management, Yale University, New Haven, Connecticut, United States
Jason L. Schwartz
Affiliation:
Department of Health Policy and Management, Yale University, New Haven, Connecticut, United States
*
Corresponding author: Audrey D. Zhang; Email: [email protected]
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Abstract

This study characterizes 2008-2022 FDA advisory committee discussions of new supplemental indication applications that were not approved by FDA. Discussion themes included contextual concerns unique to already-approved drugs, including insights from prior experience and concerns about off-label use, and efficacy and safety concerns also observed for new drugs. These findings highlight advisory committees’ role in transparency of regulatory decision-making, specifically for drugs already authorized for use.

Keywords

US Food and Drug Administrationadvisory committeessupplemental indications
Type
Independent Articles
Information
Journal of Law, Medicine & Ethics , First View , pp. 1 - 8
Copyright
© The Author(s), 2025. Published by Cambridge University Press on behalf of American Society of Law, Medicine & Ethics

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