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Gattex Review Shows FDA Approach On MedGuides Outside REMS

 
• By Sue Sutter

FDA said a Medication Guide need not be encompassed within NPS Pharma’s proposed Risk Evaluation and Mitigation Strategy for teduglutide due to the extensive interactions between short bowel syndrome patients and their health care providers and the inclusion of other patient-directed materials.

The Gastrointestinal Drugs Advisory Committee’s Oct. 16 review of NPS Pharmaceuticals Inc.’s short bowel syndrome drug Gattex (teduglutide) provided a look into how FDA decides whether a Medication Guide should be placed within the purview of a Risk Evaluation and Mitigation Strategy or outside of it.

FDA’s views on whether a MedGuide fits within a REMS are shaped, in part, by the degree of patient interaction...

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