Regulatory Data Insights and Methods of Extraction and Analysis

This study investigates trends in FDA warning letter issuance between 2019 and 2023, focusing on the agency's efficiency and evolving priorities during this period. By analyzing both quantitative and qualitative data, the research highlights an increase of 43% in warning letters issued per 100 inspections. Using a novel approach combining regex filtering and web scraping, this presentation examines recurring keywords, department-specific citations, and legal references. The analysis aims to help attendees understand how structured data from regulatory agencies can be harnessed to improve compliance and inspection readiness.

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Publication Details

Journal
PDA Journal of Pharmaceutical Science and Technology
Published
2025-01-01
DOI
https://doi.org/10.5731/pdajpst.2025.25410
Primary Topic
Pharmaceutical industry and healthcare
Type
article
Field-Weighted Citation Impact
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article

Regulatory Data Insights and Methods of Extraction and Analysis

George Kwiecinski, Zephaniah Odidika
PDA Journal of Pharmaceutical Science and Technology
Pharmaceutical industry and healthcare
article

Regulatory Data Insights and Methods of Extraction and Analysis

George Kwiecinski, Zephaniah Odidika
article en

Abstract

This study investigates trends in FDA warning letter issuance between 2019 and 2023, focusing on the agency's efficiency and evolving priorities during this period. By analyzing both quantitative and qualitative data, the research highlights an increase of 43% in warning letters issued per 100 inspections. Using a novel approach combining regex filtering and web scraping, this presentation examines recurring keywords, department-specific citations, and legal references. The analysis aims to help attendees understand how structured data from regulatory agencies can be harnessed to improve compliance and inspection readiness.

PDA Journal of Pharmaceutical Science and TechnologyVol. 79(4)
Public Health Solutions (US)
Openalex Percentile: Top 74%
Pharmaceutical industry and healthcare
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