A Review of FDA Guidance
نویسنده
چکیده
16.15.03-022010 Introduction Following publication of the December 2008 FDA Guidance for Industry Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes, assessment of cardiovascular safety has become a critical focus during the development of new antidiabetic therapies for Type 2 diabetes mellitus (T2DM). The importance of this guidance document, referred to from here on as “the Guidance,” was evidenced by a September 2009 conference, Cardiovascular Safety and Development of Type 2 Diabetes Mellitus Medications: Current State of the Art and Opportunities to Advance the Science, sponsored by the Drug Information Association, the US Food and Drug Administration (FDA), and the Cardiac Safety Research Consortium. This White Paper provides a brief historical perspective on the evolution of the Guidance, reviews its central tenets, and discusses their implications for the development of new antidiabetic therapies for T2DM. Understanding the FDA Guidance on Assessing Cardiovascular Risks for new Antidiabetic Therapies. A Review of FDA Guidance
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