Part I provides an overview of the history of formalized cardiac safety assessment, a brief discussion of the dedicated study used to investigate a drug’s propensity to increase the length of the QT interval and a review of the regulatory history of formalized cardiovascular safety assessment for antidiabetic drugs for T2DM.

Part II, to be published in the February issue of Regulatory Focus, will discuss key aspects of FDA’s guidance for industry on cardiovascular safety assessment published in December 2008 and the continuing discussion in the literature regarding the cardiovascular safety of Avandia and Actos, provide insight into the FDA’s July 2010 Advisory Committee meeting on Avandia, briefly discuss the EMA’s January 2010 draft guidance, and end with a discussion of potential ramifications for the future global development of antidiabetic drugs for T2DM.

Regulatory Focus 16:1 43-48