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FDA Raising Approval Bar For NSAID/PPI Combos; Endpoints Under Review

This article was originally published in RPM Report

Executive Summary

Regulatory briefings don't always just affect a single product; they can also be convened to discuss the regulatory parameters for a entire product class. One such briefing will be held in early 2009 to discuss the clinical trial design of NSAID/PPI combination products. Pozen is just one sponsor that will be affected by the outcome.

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