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ROCHE AMPLICOR QUANTITATIVE HIV TEST APPROVAL FOR PATIENT MONITORING RECOMMENDED BY FDA ADVISORY PANEL; PMA SUPPLEMENT BASED ON AIDS DRUG STUDY

This article was originally published in The Gray Sheet

Executive Summary

Roche Molecular Systems' Amplicor HIV-1 Monitor test kit should be approved as an aid in managing patients receiving anti-viral therapy for HIV infection, FDA's Blood Products Advisory Committee unanimously concluded at a Dec. 12 meeting in Rockville, Maryland.

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