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Kalyani Participates in FDA Panel

Rita Kalyani, associate professor in the Division of Endocrinology, participated in the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration. The committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic disorders, and makes appropriate recommendations to the Commissioner of Food and Drugs.

During a meeting last month, the committee declined to recommend approving a low-dose version of empagliflozin (Jardiance) for adults with type 1 diabetes.

She was quoted in an article about the decision in Medpage Today: SGLT2 Drug for T1D Gets Thumbs Down From FDA Panel— Voting members picked apart trial's "inadequate" data


Kelsey Bennett