Last month, in Part I of this two-part series, we provided 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/QTc interval, and an overview of the regulatory history of formalized cardiovascular safety assessment for antidiabetic drugs for Type 2 Diabetes Mellitus (T2DM).

Part II discusses key aspects of the US Food and Drug Administration’s (FDA) December 2008 Guidance for Industry Diabetes Mellitus—Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes, continuesthe discussion in the literature regarding the cardiovascular safety of Avandia and Actos, provides insights into the July 2010 FDA Advisory Committees Meeting on Avandia and a brief discussion of the European Medicines Agency’s (EMA) January 2010 Draft Guidance for T2DM, and ends with a discussion regarding the potential ramifications for future global development of antidiabetic drugs for the treatment of T2DM.

Regulatory Focus 16:2 38-42