Trinity Biotech to submit IND for Uni-Gold HIV test within next three months.
This article was originally published in The Gray Sheet
Executive Summary
TRINITY BIOTECH UNI-GOLD HIV TEST INVESTIGATIONAL NEW DRUG SUBMISSION is expected within the next three months, the Dublin, Ireland-based company says. Clinical trials for the product will be conducted under FDA's new drug/biologic investigation procedures, and the company will attempt to bring the one-step HIV assay to market via a product license application (PLA) that will be reviewed by FDA's Center for Biologics Evaluation and Research. FDA is requiring Trinity to submit a PLA rather than a premarket approval application since the assay potentially could be used to screen blood, the firm explains.
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