What AI Evaluation Means for Medical Writing AI evaluation in medical writing requires more than asking whether an output “looks good.” A strong AI medical writing validation process needs explicit criteria for accuracy, consistency, traceability, and defensibility before AI-assisted content can be considered acceptable. One of the quiet challenges in AI-assisted medical writing is evaluation. Not whether AI can produce usable text but how teams decide whether that text i

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

In the evolving landscape of regulatory writing, it has become clear that creating clear and compliant documents is no longer enough. Building off the principles of lean authoring, regulatory writers must now consider holistically the experience of those who will review the documents.

What is a Biosimilar? In the scientific realm, biosimilars, akin to their reference products, are biologic medications. Approval for biosimilars hinges on demonstrating no clinically significant differences in safety and efficacy compared to the reference products.

In recent years, lean authoring principles have emerged as a cornerstone for efficient and effective communication. These principles, which emphasize planning, avoiding redundancy, and using precise language, are especially relevant in technical and professional writing.

In the rapidly evolving landscape of artificial intelligence (AI), the 11 × 11 tipping point has emerged as a critical concept. This tipping point refers to the moment when AI technologies reach an optimal level of efficiency and effectiveness.

Prepare for a successful Quality Control review! Download this poster, presented by Synterex at the 2023 American Medical Writers Association (AMWA) conference, or scroll down for a text-only version.