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Combo PPI/NSAID Products May Escape Outcomes Studies Despite Split FDA Panel Vote

This article was originally published in The Pink Sheet Daily

Executive Summary

Gastrointestinal Drugs Advisory Committee says endoscopically diagnosed ulcers are an appropriate surrogate endpoint for assessing the ability of gastroprotective agents to reduce NSAID-related GI toxicity but not for evaluating the comparative GI safety of NSAIDS.

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