FDA’s “Early Communication” On Pancreatitis Risk For Incretin Mimetics Draws Clinician Ire

The possible downsides of FDA’s “Early Communication” strategy for discussing potential drug risks is again under debate after the agency announced it was reviewing preclinical data that could suggest a link between the incretin mimetics class of diabetes drugs and the risk of pancreatitis.

One clinician questions why the agency is announcing its review of non-clinical data before reaching a conclusion about what it might mean for patients