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FDA Panel Backs NPS Pharma’s Gattex But Questions Registry Plans

This article was originally published in The Pink Sheet Daily

Executive Summary

A post-approval registry for the short bowel syndrome drug needs to be rigorously designed and enroll a large proportion of patients in the orphan indication if it is to provide useful information about the drug’s long-term risks, members of FDA Gastrointestinal Drugs Advisory Committee said.

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