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眼滴质量问题:FDA能看到这个吗?

Lyla R White¹, C Michael White¹

¹School of Pharmacy, University of Connecticut, Storrs, CT, USA.

The Annals of pharmacotherapy

|February 21, 2024

概括

美国食品和药物管理局 (FDA) 缺乏主动检查的资源,特别是优先级较低的非处方 (OTC) 产品. 增加资金对于防止受污染药物的危害和确保公共安全至关重要.

科学领域:

公共卫生公共卫生
监管科学监管科学
制药制造业制药制造业制药制造业

背景情况:

美国食品和药物管理局 (FDA) 面临资源限制,影响其检查能力.
外国制造工厂的积极监督减少了,导致人们依赖于反应性,因果检查.
场外 (OTC) 产品被确定为FDA监督的较低优先级.

研究的目的:

突出FDA资源不足对公共卫生的影响.
为了强调OTC产品由于检查缺陷的脆弱性.
倡导增加FDA资金,以确保常规制造检查.

主要方法:

对FDA资源分配和检查重点的分析.
对制药产品的监管优先事项的审查.
最近与不当制造的OTC产品相关的不良事件的案例研究.

主要成果:

资源赤字阻碍了FDA进行必要的主动监督的能力.
目前的系统使消费者容易受到低质量的OTC药物的伤害.
最近的事件强调了加强监管监督的必要性.

结论:

对FDA提供足够的资金对于加强检查能力至关重要.
加强对OTC产品制造的监督对于消费者安全至关重要.
需要采取积极的监管措施,以防止广泛的公共卫生问题.

关键词:

美国食品药品监督管理局 FDA FDA 污染污染污染的污染是什么药品质量药品质量药品质量检查检查检查检查眼科医院的眼科治疗

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