FDA Advisory Committee Review of Supplemental Indications and Reasons for Non-Approval, 2008-2022
- 8 April 2025
- journal article
- review article
- Published by Cambridge University Press (CUP) in Journal of Law, Medicine & Ethics
- Vol. 53 (1) , 137-144
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
Funding Information
- Arnold Ventures
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