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Waldheim Pharmazeutika's (Austria) HIV-2 confirmatory well on its way through FDA

This article was originally published in Clinica

Executive Summary

Waldheim Pharmazeutika (Austria) says the US FDA has accepted Product and Establishment Licence Applications for its HIV-2 confirmatory immunofluorescence assay, Fluorognost HIV-2 IFA. "In spite of its huge review burden, the FDA Center of Biologics has sent the filing letter very quickly, and without requesting any further information at this point," said Dr Hermann Mucke, managing director of Waldheim's Diagnostics Division. "We believe that the Agency wants an approved HIV-2 confirmatory test out on the US market as soon as possible."

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