Chewable Tablet Adverse Events, Manufacturing Slips Prompt FDA Guidance

This article was originally published in The Pink Sheet Daily

21 Jun 2016
News

Eileen Francis eileen.francis@informa.com

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Chewable tablet manufacturers are overlooking quality attributes, leading to adverse events, according to an FDA draft guidance.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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Chewable Tablet Adverse Events, Manufacturing Slips Prompt FDA Guidance

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