Guidance for Industry on Diabetes Mellitus-Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Diabetes Mellitus-- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes." This guidance makes recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk. We are issuing this guidance for immediate implementation to ensure that relevant issues related to minimizing cardiovascular risk are considered by all sponsors who have ongoing drug development programs for type 2 diabetes.