Gattex Review Shows FDA Approach On MedGuides Outside REMS
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.
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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.
Final policy on distribution of Medication Guides and inclusion in Risk Evaluation and Mitigation Strategies makes clear what FDA considers a material change.