Bayer Immuno 1 Complexed PSA Test Ads On Hold After FDA Warning Letter
This article was originally published in The Gray Sheet
Executive Summary
Recent advertisements for Bayer's Immuno 1 complexed prostate specific antigen assay are "inaccurate" and "misleading" in that they wrongly imply cPSA is "cancer specific" and that the assay is intended for prostate cancer detection instead of monitoring, FDA says in an Aug. 25 warning letter.