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Structured Content Management Meets AI: Enhancing Health Authority Interactions
Discover how AI and structured content management are transforming regulatory submissions—boosting speed, consistency, and compliance in health authority interactions.

Elizabeth Patterson
Jun 18


Why ELSA Is a Step—but Not the Destination—for AI in Regulatory Writing
The FDA’s recent Evaluation of Labeling Submissions with AI (ELSA) pilot program has generated both curiosity and skepticism in the regulatory community. Early responses from reviewers using ELSA have been mixed, with some finding it helpful for catching inconsistencies or typos, while others found it redundant or disconnected from their workflows. While the effort is laudable, the ELSA pilot highlights deeper limitations in how general-purpose AI tools perform in complex, re

Jeanette Towles
Jun 11


Reducing Redundancy: How Structured Content and AI Reduce Rework in Medical Writing
Integrating technology-assisted content reuse into medical writing can reduce stress for writers by preventing unnecessary rework and maintaining consistent document quality and compliance. This ensures timely delivery of important new therapies to the patients who need them.

Katelyn Rivas
Jun 5
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