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Diabetes Drugs: Longer, Broader Phase II/III Trials Could Replace CV Outcomes Trials, US Panel Says

Executive Summary

Premarketing trials that enroll more diverse patient populations and include targeted CV endpoint collection over longer periods of time could be sufficient to allow new type 2 diabetes drugs to reach market without need for a dedicated safety study, advisory committee members say, urging FDA to move away from current two-step approach to cardiovascular risk assessments.

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