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

IF 1.6 4区哲学 Q2 ETHICS

Journal of Law Medicine & Ethics Pub Date : 2025-04-08 DOI:10.1017/jme.2025.53

Audrey D Zhang, Nikhil Chaudhry, Reshma Ramachandran, Joseph S Ross, Jason L Schwartz

引用次数: 0

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.

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来源期刊

Journal of Law Medicine & Ethics 医学-医学：法

CiteScore

2.90

自引率

4.80%

发文量

审稿时长

6-12 weeks

期刊介绍： Material published in The Journal of Law, Medicine & Ethics (JLME) contributes to the educational mission of The American Society of Law, Medicine & Ethics, covering public health, health disparities, patient safety and quality of care, and biomedical science and research. It provides articles on such timely topics as health care quality and access, managed care, pain relief, genetics, child/maternal health, reproductive health, informed consent, assisted dying, ethics committees, HIV/AIDS, and public health. Symposium issues review significant policy developments, health law court decisions, and books.