{"title":"A Communication Effectiveness Study of the FDA GMP Warning Letters","authors":"Yiyi Bao, Qiang Zheng","doi":"10.1007/s12247-024-09844-8","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><p>Study the structure and content trend over time of the FDA GMP Warning Letters for their roles in effective communication.</p><h3>Methods</h3><p>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.</p><h3>Results</h3><p>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.</p><h3>Conclusions</h3><p>Warning Letters have become increasingly informative, showing FDA’s good practice of transparency as a way to improve regulatory effectiveness.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"19 3","pages":""},"PeriodicalIF":2.7000,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Pharmaceutical Innovation","FirstCategoryId":"3","ListUrlMain":"https://link.springer.com/article/10.1007/s12247-024-09844-8","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
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.
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.
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