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2019 Apr 24;5(1):e000528
A Pivotal Contribution from Regulatory Agencies To Relevant Clinical Observations The requirements to assess the safety of new diabetes medications, including GLP-1R agonists, set forth by The United States Food and Drug Administration (FDA) were specified in the December 2008 guidance document titled Guidance for Industry: Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. A draft of this document had been issued in March 2008 and the final document followed recommendations from the Endocrinologic and Metabolic Drugs Advisory Committee that convened on July 1 and 2, 2008 [25]
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Biology of the Neonate, 63 (4), 201-208
