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Restoring FDA’s Confidence In Labeling

This article was originally published in RPM Report

Executive Summary

FDA’s decision to harmonize immediate-release and extended-release opioid labeling is an important step to address a political vulnerability for the agency and its new commissioner. But Commissioner Califf’s discussion of the role of FDA-approved labeling may be more important as an indicator of the overall drug approval climate – and a path forward in the thicket of First Amendment challenges to the agency’s marketing oversight.

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