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Metabolic Disorders Advisory Committees Regulation

Sanofi's Sotagliflozin: Risk Of Ketoacidosis Divides US FDA Advisory Committee

  • Analysis

Executive Summary

Some Endocrinologic and Metabolic Drugs Advisory Committee members said a REMS is sufficient, but others worried that proposed risk management plans were not proven effective.
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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