FDA GMP 警告信的沟通效果研究

IF 2.7 4区医学 Q2 PHARMACOLOGY & PHARMACY Journal of Pharmaceutical Innovation Pub Date : 2024-06-01 DOI:10.1007/s12247-024-09844-8

Yiyi Bao, Qiang Zheng

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引用次数: 0

摘要

目的研究 FDA GMP 警告信的结构和内容随时间变化的趋势，以了解其在有效沟通中的作用。方法使用基于函数的文本解析、手动着色和 Python 自动化相结合的方法研究警告信的结构和内容随时间变化的趋势。结果使用这些方法观察到的趋势表明，关于如何回应警告信、第三方参与和进一步阅读的建议内容随时间的推移持续增加。

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A Communication Effectiveness Study of the FDA GMP Warning Letters

Purpose

Study the structure and content trend over time of the FDA GMP Warning Letters for their roles in effective communication.

Methods

The structure and content trend over time of Warning Letters are studied using a combination of parsing text based on function, manual coloring and Python automation.

Results

The observed trends using these methods indicate that the content of suggestions on how to respond to a Warning Letter, for third party participation and further reading consistently increases over time.

Conclusions

Warning Letters have become increasingly informative, showing FDA’s good practice of transparency as a way to improve regulatory effectiveness.

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来源期刊

Journal of Pharmaceutical Innovation PHARMACOLOGY & PHARMACY-

CiteScore

3.70

自引率

3.80%

发文量

审稿时长

>12 weeks

期刊介绍： The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories: Materials science, Product design, Process design, optimization, automation and control, Facilities; Information management, Regulatory policy and strategy, Supply chain developments , Education and professional development, Journal of Pharmaceutical Innovation publishes four issues a year.