FDA咨询委员会审查补充适应症和不批准的原因，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

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引用次数: 0

摘要

本研究描述了2008-2022年FDA咨询委员会对未获FDA批准的新补充适应症申请的讨论。讨论的主题包括已经批准的药物所特有的背景问题，包括来自先前经验的见解和对标签外使用的担忧，以及对新药的疗效和安全性的担忧。这些发现突出了咨询委员会在监管决策透明度方面的作用，特别是对于已经批准使用的药物。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

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

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.