US FDA rejects Lilly's PET scan drug, wants reader training program
This article was originally published in Scrip
Executive Summary
Lilly and its wholly owned subsidiary Avid Radiopharmaceuticals must establish a reader training program aimed at ensuring reader accuracy and consistency of interpretations of existing positron emission tomography (PET) scans before the firms' non-therapeutic radiopharmaceutical Amyvid (florbetapir F 18 injection) can be sold in the US for use in detecting beta-amyloid plaque in patients’ brains, the US FDA told the companies.