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Thoughts on FDA’s New Draft Guidance for T2DM Trials
FDA announced it has issued a new draft guidance titled “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control” (download draft guidance here). Of note, this new draft guidance replaces two other FDA guidance documents – the famous Dec 2008 CV risk guidance and a Feb 2008 draft guidance. The new draft guidance provides recommendations on the size and nature of the safety databases needed to improve glycemic control in T2DM patients. Below, FENIX provides a brief overview of the FDA’s new draft guidance and its implications including a favors/disfavors analysis on specific market players.