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AI in regulatory submissions: what RAG changes for filings
A major biopharmaceutical company put a peer-reviewed paper out in 2025 describing a tool that uses large language models to draft the CTD Module 2.3 Quality Overall Summary on its own. The model does not make things up. It reads several thousand pages of Module 3 quality data and boils them down into the structured QOS narrative with retrieval-augmented generation. This is the clearest public sign yet that AI has entered GxP regulatory filing. Why the quality overall summary is the right first job for AI The Common Technical Document is the format regulators use to review drug applications in the major markets. Module 3 is where the raw quality…
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Prescription Weight Loss Drugs: Science and Boundaries
Prescription weight loss drugs treat obesity and its complications. They are not cosmetic tools. Approval generally requires a BMI of 28 or above, or 24 or above with at least one related condition such as hypertension, high blood lipids, type 2 diabetes, or obstructive sleep apnea. The injections cut appetite and food intake. They only work alongside diet and exercise, and the weight comes back when you stop. What prescription weight loss drugs actually treat Here is the misunderstanding that causes most of the trouble. People think this category of medicine exists for anyone who wants to look thinner. It does not. So: you have a BMI of 23, you…