Impact of the U.S. Food and Drug Administration Cardiovascular Assessment Requirements on the Development of Novel Antidiabetes Drugs

May 2011
Diabetes Care;May2011 Supplement 2, Vol. 34, pS101
Academic Journal
The article examines the drivers for the regulations of the U.S. Food and Drug Administration related to cardiovascular (CV) safety of type 2 diabetes treatments as well as its impact on the development of novel anti-diabetes drugs. According to results of outcome studies, a surrogate biomarker of glycemic control was glycosylated hemoglobin (HbA1c. Clinical development programs for new anti-diabetes drug have mostly focused on glucose lowering according to correlation between (HbA1c and microvascular complications.


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