Safety and practicality

Diabetes patients and their physicians, along with drug developers, have been anxiously waiting to learn how FDA would apply its new safety guidelines to diabetes therapies that were studied before the new standards for cardiovascular risk had been promulgated.

After two meetings of the Endocrinologic and Metabolic Drugs Advisory Committee last week, they learned that the agency is adopting a flexible approach that permits retrospective analysis of CV data from products with completed development programs that lack the prospective, independently adjudicated CV data required in the guidance...