ARTICLE | Regulation

Premarket shadows

July 14, 2008 7:00 AM UTC

While expanded post-market surveillance to rule out rare adverse cardiovascular events for diabetes drugs appears inevitable, a new mandate from FDAto conduct extensive research to capture CV safety signals prior to market approval would dramatically alter the economics of developing new treatments for the disease.

Thus, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee broke new ground when it voted 14-2 that companies should have to look for and rule out some level of cardiovascular risks for all diabetes therapeutics prior to receiving marketing approval, even if no safety signal has been detected, as well as performing extensive post-market outcomes studies...