TITLE

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

AUTHOR(S)
HIRSHBERG, BOAZ; RAZ, ITAMAR
PUB. DATE
May 2011
SOURCE
Diabetes Care;May2011 Supplement 2, Vol. 34, pS101
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
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.
ACCESSION #
61967994

 

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