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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