In Brief: ChemTrak
This article was originally published in The Gray Sheet
Executive Summary
ChemTrak: FDA requests more information regarding the firm's premarket approval application for the Aware home HIV test service. ChemTrak submitted the PMA in February 1995 ("The Gray Sheet" Feb. 20, 1995, In Brief). The company says it will respond to FDA's request "within the standard 180-day time frame set by the agency," noting that because of the "slower than previously anticipated development of the home HIV test market" it will focus more attention on "other opportunities which offer significantly greater short-term market potential"...