FDA meeting will revisit diabetes CVOTs, decade-old controversy

An FDA advisory committee will try to unravel a knot that was tied over a decade ago when FDA and the medical community were rocked by assertions that diabetes drugs were causing deadly heart attacks.

The Oct. 24-25 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee will address whether cardiovascular outcomes trial requirements for diabetes drugs should be diminished or discarded, according to the committee's draft questions (see "FDA Advisory Committee to Consider CV Studies for Diabetes Drugs")...