Eye Drop Quality Issues: Can the FDA See This One Through?

IF 2.3 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Annals of Pharmacotherapy Pub Date : 2024-11-01 Epub Date: 2024-02-21 DOI:10.1177/10600280241233255
Lyla R White, C Michael White
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引用次数: 0

Abstract

The Food and Drug Administration (FDA) has long suffered from a lack of resources limiting their inspection capacity. They have fallen behind on proactive surveillance inspections of foreign manufacturing sites, relying instead on for-cause inspections after a problem has been discovered. Over-the-counter (OTC) products are especially vulnerable because the FDA considers them lower priority. This issue recently made big news after improperly manufactured OTC eye drops harmed users across the country, in some cases causing blindness. To prevent future harm to Americans, it is imperative that the FDA receives enough resources to keep up with their routine inspections.

眼药水质量问题:美国食品和药物管理局(FDA)能看透这一点吗?
长期以来,美国食品和药物管理局(FDA)因资源匮乏而限制了其检查能力。他们对国外生产基地的主动监督检查已经落后,转而依赖于发现问题后的原因检查。非处方药(OTC)产品尤其容易受到影响,因为 FDA 认为这些产品的优先级较低。最近,这个问题成为了大新闻,因为生产不当的非处方药眼药水伤害了全国各地的用户,在某些情况下导致失明。为了防止未来对美国人造成伤害,美国食品及药物管理局必须获得足够的资源来跟上日常检查的步伐。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
5.70
自引率
0.00%
发文量
166
审稿时长
3-8 weeks
期刊介绍: Annals of Pharmacotherapy (AOP) is a peer-reviewed journal that advances pharmacotherapy throughout the world by publishing high-quality research and review articles to achieve the most desired health outcomes.The articles provide cutting-edge information about the most efficient, safe and cost-effective pharmacotherapy for the treatment and prevention of various illnesses. This journal is a member of the Committee on Publication Ethics (COPE). Average time from submission to first decision: 14 days
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