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

 
• By Sue Sutter

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.

The adequacy of NPS Pharmaceuticals Inc.’s risk management plan for Gattex (teduglutide) will be on the table at the FDA Gastrointestinal Drugs Advisory Committee’s Oct. 16 review of the short bowel syndrome drug.

FDA intends to ask the committee whether NPS’ proposed Risk Evaluation and Mitigation Strategy containing a communication plan is adequate...

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• By Bridget Silverman

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More from North America

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• By Derrick Gingery

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• By Eliza Slawther

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