BIOMIRA'S TRUQUANT BR CA 15-3 RIA IS APPROVABLE IF FIRM ALTERS LABELING AND PROVIDES EXPLANATORY INFORMATION ON FALSE POSITIVES, PANEL SAYS
This article was originally published in The Gray Sheet
Executive Summary
Labeling for Biomira's Truquant BR CA 15-3 radioimmunoassay needs to be modified to reflect the limitations of the test before FDA clears the company's premarket approval application, the agency's Immunology Devices Advisory Panel concluded at a Sept. 21 meeting in Gaithersburg, Maryland.