Diabetes Outcomes Trial Requirement Looks 'Increasingly Wise' – FDA’s Temple
FDA’s review of novel efficacy endpoints for diabetes therapies inevitably included discussion of the future of the cardiovascular outcomes study requirement for type 2 diabetes therapies; comments by FDA and EMA officials sure make it sound like the requirement isn’t going away any time soon.
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Tearing Down The Goalposts (Part 3): “Was It Worth It”?
When US FDA adopted new outcomes standards for novel diabetes drugs in 2008, there were dire warnings that it would kill product development for the disease. When an advisory committee revisited the issue in 2018, however, there was almost unanimous agreement that the guidelines have been positive. Almost.
US FDA May Change Requirements For CV Outcomes Trials For Type 2 Diabetes Drugs
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