Diabetes safety test

FDA has privately informed companies with active INDs for diabetes drugs about its new standards for premarket assessment of cardiovascular risk, but hasn't yet made them public. The agency's guidance indicates it has charted a middle path between safety advocates who want CV outcomes trials prior to approval, and those who feel that in the absence of adverse safety signals, diabetes drugs should be approved if they provide glucose control.

Letters sent over the last six weeks to diabetes companies indicate that, prior to approval, FDA will require data that rule out the possibility a drug increases cardiovascular risk by 80%...