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NPS Pharma’s REMS For Gattex Will Face FDA Panel Scrutiny

This article was originally published in The Pink Sheet Daily

Executive Summary

In briefing documents released ahead of the Oct. 16 Gastrointestinal Drugs Advisory Committee review, FDA suggests there is room for improvement in NPS’ communication plan for the short bowel syndrome treatment teduglutide to convey serious risks about malignancy and polyp growth and GI obstruction.

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