Biomira Truquant BR approval pending January 1996 FDA premarket inspection.
This article was originally published in The Gray Sheet
Executive Summary
BIOMIRA TRUQUANT BR CLEARANCE AWAITS FDA PREAPPROVAL INSPECTION slated for January 1996, the company says. Biomira has "completed all conditions" spelled out by FDA in a recent approvable letter for the premarket approval application for Truquant BR, a blood test intended for use as an "independent predictor of recurrence of breast cancer in women with Stage II and Stage III disease," the company said in a Dec. 14 press release. The only remaining hurdle to approval is a successful inspection of its manufacturing facilities in Toronto.
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