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FDA Takes Its Tablet-Scoring Guidance To An Advisory Committee

This article was originally published in The Pink Sheet Daily

Executive Summary

On Aug. 9, FDA’s Pharmaceutical Science and Clinical Pharmacology panel will discuss the agency’s year-old draft guidelines on the data needed to support functional scoring of tablets. Issues related to tablet scoring as a purported strategy for delaying generic entry are at the heart of Mylan’s recent lawsuit against Doryx marketer Warner Chilcott.

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