Groups Dislike FDA-Recommended Trial Designs For Low-Glucose Suspend Systems
This article was originally published in The Gray Sheet
Executive Summary
FDA’s recommended trial designs for early versions of “artificial pancreas” devices for type 1 diabetes patients are overly burdensome and will hinder development in the space, device makers and clinical societies say.
You may also be interested in...
FDA Releases Draft Guidance On Closed-Loop Artificial Pancreas Devices
Draft issued Dec. 1 emphasizes flexible clinical trial designs to support approval of glucose monitor/insulin pump combination devices that work together without the need for patient intervention.
Regulatory News In Brief
Contura’s Aquamid advisory panel delayed