FDA agrees to review Point Biomedical's CAD (coronary artery disease) ultrasound agent:
This article was originally published in Clinica
Executive Summary
The US FDA has accepted for review Point Biomedical's application to market its CARDIOsphere (PB127) ultrasound imaging agent for assessing coronary artery disease (CAD). The San Carlos, California firm said that under PDUFA (Prescription Drug User Fee Act) III, the FDA's goal is to review and act on the marketing application by late October 2006.