Thera-Business is pleased to announce the publication of a new article, “AI in Regulatory Writing: Examining Critical Pitfalls and Implications,” in the November–December 2026 issue of the RAPS Journal of Regulatory Affairs.
Authored by Dr. Red Thaddeus D. Miguel, Rami Ali, and Manal El Joumaa, the article examines the growing use of artificial intelligence (AI) in regulatory writing, highlighting critical risks and practical recommendations for maintaining accuracy, data integrity, and regulatory compliance.
Regulatory agencies have observed an increase in the use of artificial intelligence (AI) within regulatory writing workflows. This trend has also increased demand for critical evaluation of these practices. While AI tools offer opportunities to improve writing efficiency and document management, they introduce significant risks related to data security, privacy, accuracy, traceability, tone, and interpretation. This article outlines key pitfalls in AI-generated regulatory content and provides actionable recommendations for ensuring clarity, credibility, and compliance in AI-assisted submissions.
Citation: Miguel RTD, et al. AI in regulatory writing: Examining critical pitfalls and implications. RAPS Journal of Regulatory Affairs. 2026;1(6):16-23. Published online 3 November 2026.
Read the article: AI in Regulatory Writing: Examining Critical Pitfalls and Implications
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