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FDA to Revise Safety Evaluation of Type 2 Diabetes Drugs

The US Food and Drug Administration (FDA) has issued new draft guidance for industry on evaluating the safety of new drugs for type 2 diabetes and removed the "outdated" 12-year-old requirement for standardized cardiovascular outcomes trials (CVOTs).

The new draft guidance, "Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control," will replace the December 2008 requirement that manufacturers conduct CVOTs to rule out unacceptable cardiovascular safety risk.