通过非处方药扩大药品供应。

IF 2 4区 医学 Q4 MEDICAL INFORMATICS Therapeutic innovation & regulatory science Pub Date : 2024-10-20 DOI:10.1007/s43441-024-00709-3
Terra Marie M Jouaneh, Vrushab Gowda, Brian J Miller
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引用次数: 0

摘要

本评论针对美国食品和药物管理局 (FDA) 最近提出的通过附加非处方药使用条件 (ACNU) 扩大非处方药使用范围的规则。它调查了药品进入市场的各种途径,指出了非处方药 (OTC) 产品有别于处方药产品的独特要求。报告随后回顾了 ACNU 拟议规则,权衡了其潜在益处和可能存在的局限性。展望未来,ACNU 拟议规则被认为是长期传统的一部分,即以风险分级的方式扩大药品渠道,同时加强临床监督,以应对日益增加的消费者风险。最后,拟议的规则也是未来非处方药途径的潜在前奏。
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Expanding Pharmaceutical Access Via Over the Counter Drugs.

This commentary addresses the recent U.S. Food & Drug Administration (FDA) proposed rule to expand access to nonprescription drugs through additional conditions of nonprescription use (ACNU). It surveys the various pathways to market for pharmaceutical products, noting the distinct requirements for over-the-counter (OTC) products differentiating them from prescription products. It subsequently reviews the ACNU proposed rule, weighing its potential benefits against possible limitations. With a view towards the future, the ACNU proposed rule is acknowledged as part of a longstanding tradition to expand drug channels in a risk-stratified fashion with increasing clinical oversight to address in tandem increasing consumer risks. Finally, the proposed rule also serves as a potential prelude for a future behind the counter drug pathway.

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来源期刊
Therapeutic innovation & regulatory science
Therapeutic innovation & regulatory science MEDICAL INFORMATICS-PHARMACOLOGY & PHARMACY
CiteScore
3.40
自引率
13.30%
发文量
127
期刊介绍: Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health. The focus areas of the journal are as follows: Biostatistics Clinical Trials Product Development and Innovation Global Perspectives Policy Regulatory Science Product Safety Special Populations
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