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

机译:工业糖尿病指南 - 评估新型抗糖尿病治疗2型糖尿病的心血管风险

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This guidance provides recommendations for the development of drugs and therapeutic biologics regulated within the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA) for the treatment of diabetes mellitus. Specifically, 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. In March 2008, the FDA issued the draft guidance for industry Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention.3 Concerns related to cardiovascular risk will be addressed in the final version of that guidance. In the meantime, we are issuing this final guidance for immediate implementation to ensure that relevant issues related to minimizing cardiovascular risk are considered in ongoing drug development programs. We will address cardiovascular risk assessment for currently marketed antidiabetic therapies in a separate guidance.

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