FDA-Ordered Postmarket Studies for Drugs and Devices Frequently Delayed, Raising Safety Concerns

A KFF Health News analysis reveals that hundreds of postmarket studies mandated by the FDA for approved drugs and medical devices are delayed, some by over a decade. This lack of follow-through leaves patients and doctors without crucial information on product risks and benefits, as exemplified by a delayed safety study for Amgen's drug Tavneos, which has been linked to dozens of liver damage cases.