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BioPharmaceutical Consumer United States

Chewable Tablet Adverse Events, Manufacturing Slips Prompt FDA Guidance

This article was originally published in The Pink Sheet Daily

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Executive Summary

Chewable tablet manufacturers are overlooking quality attributes, leading to adverse events, according to an FDA draft guidance. The agency recommends firms establish hardness, dissolution and disintegration of products early in manufacturing.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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