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2013 Diabetes NMEs Span Classes, But Safety Is A Review Issue For All

Executive Summary

The repercussions of FDA’s 2008 guidance on cardiovascular risk evaluation in diabetes trials are still being felt in reviews of new agents. Pending applications include two GLP-1 agonists, the third review of a DPP-IV inhibitor, a possible first-in-class SGLT-2 inhibitor and a long-acting basal insulin, and safety is a major review issue for all of them.

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